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Globe and Mail
02-07-2025
- Business
- Globe and Mail
Idiopathic Membranous Nephropathy Market Analysis 2034: Clinical Trials, EMA, PDMA, FDA Approvals, Prevalence, Statistics, Revenue, Therapies, Companies by DelveInsight
"Idiopathic Membranous Nephropathy Market" Idiopathic Membranous Nephropathy companies include Bristol Myers Squibb Company, Merck and Co Inc., Mylan Pharmaceutical ltd., Novartis AG, Pfizer Inc., Roche, Aspen Global Inc., Astellas Pharma Inc., Baxter Healthcare Corporation, Sigma Aldrich Corporation, and others. (Albany, USA) DelveInsight's " Idiopathic Membranous Nephropathy Market Insights, Epidemiology, and Market Forecast-2034" report delivers an in-depth understanding of Complicated Urinary Tract Infection (cUTI), historical and forecasted epidemiology as well as the Complicated Urinary Tract Infection (cUTI) market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom), and Japan. The Idiopathic Membranous Nephropathy market growth is driven by factors like increase in the prevalence of Idiopathic Membranous Nephropathy, investments in research and development, entry of emerging therapies during the study period 2020-2034. The Idiopathic Membranous Nephropathy market report also offers comprehensive insights into the Idiopathic Membranous Nephropathy market size, share, Idiopathic Membranous Nephropathy epidemiology, emerging therapies, market drivers and barriers, ongoing clinical trials, key collaboration in the space, market uptake by key therapies and companies actively pushing Idiopathic Membranous Nephropathy market size growth forward. Some of the key highlights from the Idiopathic Membranous Nephropathy Market Insights Report: The Idiopathic Membranous Nephropathy market size in the 7MM is expected to reach ~USD 1,000 million by 2034. Several key pharmaceutical companies, including Bristol Myers Squibb Company, Merck and Co Inc., Mylan Pharmaceutical ltd., Novartis AG, Pfizer Inc., Roche, Aspen Global Inc., Astellas Pharma Inc., Baxter Healthcare Corporation, Sigma Aldrich Corporation, and others, are developing novel products to improve the Idiopathic Membranous Nephropathy treatment outlook. In 2023, the United States represented around 40% of all prevalent cases of Idiopathic Membranous Nephropathy across the 7MM. Data from Japan indicates that the prevalence of Idiopathic Membranous Nephropathy is expected to remain relatively stable from 2024 to 2034. Among the EU4 countries and the UK, Germany had the highest prevalence of the condition, accounting for about 30% of cases, followed by the UK with approximately 20% in 2023. In the same year, PLA2R-specific cases in the EU4 and the UK made up about 75% of the total cases in the 7MM. The market for Idiopathic Membranous Nephropathy (IMN) across the 7MM is projected to reach approximately USD 1,000 million by 2034. In 2023, the United States holds the largest market share, with around USD 88 million, compared to EU4 (Germany, Spain, Italy, France), the United Kingdom, and Japan. IMN is a major type of glomerular disease, marked by high protein levels in the urine (nephrotic syndrome) and is primarily autoimmune in nature. Currently, there are no specific approved treatments for IMN, and management mainly involves supportive care. The market is expected to experience significant growth due to the increased use of existing drugs, the anticipated launch of new therapies, and growing awareness. The total number of prevalent IMN cases in the 7MM is estimated to be about 71,000 in 2023. Of these, the US represents approximately 40% of the cases, while the EU4 and the UK together account for around 35%, and Japan contributes roughly 25%, making Japan the second-largest contributor after the US. Several promising drugs in the pipeline include TNT119, ALPN-303, MOR202, SNP-ACTH (1-39) Gel, and GAZYVA. In December 2024, SynAct Pharma Aps announced results of an Exploratory, Randomized, Double-blind, Multicenter, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of AP1189 Versus Placebo Administered for 12 Weeks as an add-on to Patients, in ACE Inhibitor or Angiotensin II Receptor Blocker Treatment, With Idiopathic Membranous Nephropathy and Severe Proteinuria In October 2023, Human Immunology Biosciences (HI-Bio) received FDA's Breakthrough Therapy designation for felzartamab to treat primary membranous nephropathy. In June 2023, the FDA granted orphan drug designation to SNP-ACTH (1-39) gel for primary membranous nephropathy. Additionally, Biogen completed its acquisition of HI-Bio in July 2024. In June 2022, HI-Bio and MorphoSys AG entered into a licensing agreement for the development and commercialization of MorphoSys' anti-CD38 antibody, felzartamab. In the 7MM, MOR202 (felzartamab) is projected to generate the highest market revenue, reaching around USD 500 million by 2034. Within the EU4 and the UK, Germany had the largest market size, totaling approximately USD 10 million in 2023. As per DelveInsight analysis, the Idiopathic Membranous Nephropathy market is anticipated to witness growth at a considerable CAGR Idiopathic Membranous Nephropathy Overview Idiopathic Membranous Nephropathy (IMN) is a common form of glomerular disease primarily linked to nephrotic syndrome. It occurs when the immune system attacks the glomeruli, resulting in significant protein loss in the urine, swelling, and the potential for kidney failure. The condition is labeled "idiopathic" when no clear secondary cause is identified, though it can be triggered by various underlying factors such as autoimmune diseases or infections. IMN generally affects adults, especially middle-aged men, and presents with symptoms like frothy urine, swelling in the legs and abdomen, and weight gain due to fluid buildup. Diagnosing IMN involves both clinical evaluation and laboratory tests. Initial tests include urine analysis to detect high levels of protein (usually over 3.5 g/day), which is characteristic of nephrotic syndrome. Blood tests are used to assess kidney function and identify hypoalbuminemia and dyslipidemia, both common in nephrotic syndrome. A kidney biopsy is often needed to confirm the diagnosis, revealing typical changes in the glomeruli, such as immune complex deposits along the capillary walls. Additionally, serological tests for specific antibodies, like those targeting the phospholipase A2 receptor (PLA2R), can help distinguish primary IMN from secondary forms, aiding in the development of appropriate treatment plans. Idiopathic Membranous Nephropathy Epidemiology Segmentation DelveInsight's Idiopathic Membranous Nephropathy market report is prepared on the basis of epidemiology model. It offers comprehensive insights to the Idiopathic Membranous Nephropathy historical patient pools and forecasted Idiopathic Membranous Nephropathy patients. The report provides in-depth data of various subtypes and for the same epidemiology is segmented further. The Idiopathic Membranous Nephropathy Market report proffers epidemiological analysis for the study period 2020-34 in the 7MM segmented into: Idiopathic Membranous Nephropathy Prevalence Age-Specific Idiopathic Membranous Nephropathy Prevalence Gender-Specific Idiopathic Membranous Nephropathy Prevalence Diagnosed and Treatable Cases of Idiopathic Membranous Nephropathy Idiopathic Membranous Nephropathy Market Outlook The Idiopathic Membranous Nephropathy (IMN) market is driven by several key factors, including the rising prevalence of chronic kidney diseases globally, improved diagnostic capabilities enabling early detection, and increased awareness among physicians and patients. The development of novel biomarkers and targeted biologics, along with the growing adoption of personalized medicine approaches, are also fueling market growth. Additionally, supportive reimbursement policies and ongoing clinical trials exploring innovative therapies contribute to market expansion. However, significant barriers persist, such as the high cost of advanced treatments and limited accessibility in low- and middle-income regions. The heterogeneity of disease progression complicates clinical management, often delaying optimal intervention. Moreover, stringent regulatory requirements and lengthy approval timelines for new therapeutics pose challenges for manufacturers. A lack of comprehensive long-term safety data on emerging therapies and concerns regarding potential adverse effects further restrict widespread adoption. Together, these drivers and barriers shape the evolving landscape of the IMN market, highlighting both opportunities for advancement and areas requiring strategic focus to address unmet needs. Major companies like Hoffmann-La Roche, HI-Bio, Cerium Pharmaceuticals, BeiGene, and others are advancing their lead candidates through various stages of clinical development, with the goal of exploring their products for the treatment of Idiopathic Membranous Nephropathy. Idiopathic Membranous Nephropathy Emerging Drugs Idiopathic Membranous Nephropathy Key Companies Bristol Myers Squibb Company, Merck and Co Inc., Mylan Pharmaceutical ltd., Novartis AG, Pfizer Inc., Roche, Aspen Global Inc., Astellas Pharma Inc., Baxter Healthcare Corporation, Sigma Aldrich Corporation, and others Scope of the Idiopathic Membranous Nephropathy Market Report: 10 Years Forecast 7MM Coverage Descriptive overview of Idiopathic Membranous Nephropathy, causes, signs and symptoms, diagnosis, treatment Comprehensive insight into Idiopathic Membranous Nephropathy epidemiology in the 7MM Idiopathic Membranous Nephropathy marketed and emerging therapies Idiopathic Membranous Nephropathy companies Idiopathic Membranous Nephropathy market drivers and barriers Table of Contents: 1 Idiopathic Membranous Nephropathy Market Key Comprehensive Insights 2 Idiopathic Membranous Nephropathy Market Report Introduction 3 Competitive Intelligence Analysis for Idiopathic Membranous Nephropathy 4 Idiopathic Membranous Nephropathy Market Analysis Overview at a Glance 5 Executive Summary of Idiopathic Membranous Nephropathy 6 Idiopathic Membranous Nephropathy Epidemiology and Market Methodology 7 Idiopathic Membranous Nephropathy Epidemiology and Patient Population 8 Idiopathic Membranous Nephropathy Patient Journey 9 Idiopathic Membranous Nephropathy Treatment Algorithm, Idiopathic Membranous Nephropathy Current Treatment, and Medical Practices 10 Key Endpoints in Idiopathic Membranous Nephropathy Clinical Trials 11 Idiopathic Membranous Nephropathy Marketed Therapies 12 Idiopathic Membranous Nephropathy Emerging Therapies 13 Idiopathic Membranous Nephropathy: 7 Major Market Analysis 14 Attribute analysis 15 Access and Reimbursement Overview of Idiopathic Membranous Nephropathy 16 Idiopathic Membranous Nephropathy Market Key Opinion Leaders Reviews 18 Idiopathic Membranous Nephropathy Market Drivers 19 Idiopathic Membranous Nephropathy Market Barriers 20 SWOT Analysis 21 Disclaimer 22 DelveInsight Capabilities 23 About DelveInsight About DelveInsight DelveInsight is a leading Life Science market research and business consulting company recognized for its off-the-shelf syndicated market research reports and customized solutions to firms in the healthcare sector. Media Contact Company Name: DelveInsight Business Research LLP Contact Person: Ankit Nigam Email: Send Email Phone: +14699457679 Address: 304 S. Jones Blvd #2432 City: Albany State: New York Country: United States Website:
Medscape
13-06-2025
- Health
- Medscape
Flu Shot Sparks False HIV Alarm in Dialysis Patient
False-positive HIV test results following influenza vaccination are rare. However, unexpected cross-reactivity remains a concern in the evolution of vaccine formulations. After obtaining her annual flu shot, an 82-year-old woman on haemodialysis (HD) was repeatedly discovered to have positive HIV enzyme-linked immunosorbent assay (ELISA) test results without having risk factors, and previously, the test was negative. Only a more detailed medical history revealed a possible unexpected explanation. A case report by Rayyan Mkahal,MD, a nephrology fellow at the University of Toronto, Toronto, Ontario, Canada, and his colleagues highlights the potential often-overlooked complications associated with the flu vaccine. The Patient and Her History The patient presented for HD with end-stage kidney disease on intermittent HD in one of the dialysis centres. Her medical history was otherwise significant for diabetes mellitus and dyslipidaemia. At the start of HD, the HIV ELISA test result was negative. However, 7 months later, during routine testing, she was unexpectedly found to have a positive HIV ELISA. The patient had never received a blood transfusion and was not sexually active. The patient was clinically stable without evidence of active infection, weight loss, night sweats, fever, chills, or other systemic symptoms. She has no reported recent travel. Findings and Diagnosis On admission, her vital signs, including blood pressure, heart and respiratory rates, oxygen saturation on room air, and temperature, were all within normal limits. Complete blood cell count was within the normal range. Otherwise, her immunisation history included a hepatitis B vaccine before initiating dialysis and yearly flu vaccination, the most recent of which was administered approximately 45 days before detection. Her previous COVID booster vaccine was administered 4 months ago. No illnesses, hospitalisations, or major interim events have occurred since dialysis initiation. Other probable causes of false-positive ELISA results, such as autoimmune diseases, malignancy, or recent infections, were considered but were not supported by clinical history or laboratory evaluation. An HIV polymerase chain reaction was performed 14 weeks after the initial positive test and revealed no viral replication. No HIV testing was performed between weeks 3 and 14; therefore, the precise timing of seroconversion remains unknown. Discussion 'Despite the use of relatively new vaccine formulations, cross-reactivity with ELISA remains a relevant phenomenon. Given that influenza vaccines are given annually, clinicians must remain vigilant to avoid misdiagnosis and treatment. This case highlights the need for increased awareness of this phenomenon and suggests future research to explore the persistence of vaccine-antibody interference in the vulnerable population,' the study authors wrote.
Medscape
06-06-2025
- Health
- Medscape
A PCP Guide to Emerging Therapies for Resistant Hypertension
This transcript has been edited for clarity. Matthew F. Watto, MD: Welcome back to The Curbsiders . I'm Dr Matthew Frank Watto, here with my great friend and America's primary care physician, Dr Paul Nelson Williams. Paul, this is a topic you know a ton about, isn't it? Paul N. Williams, MD: It's one I always have questions about; I think this is our 37th episode on high blood pressure, if I'm not mistaken. Watto: The audience can't get enough of it — turns out, neither can I. Williams: Me neither! Watto: I love talking about high blood pressure, and this was with a great guest, Dr Jordy Cohen. She's a hypertension expert and a nephrologist. Paul, to start us off, what are we doing with blood pressure cuffs these days? Those manual ones on the wall, those are the way to go, right? Williams: This is a scenario we talk about all the time, and we've beat this drum a lot in prior episodes. I think we've all experienced a patient whose initial triage blood pressure reading is elevated, and either you or the patient will ask for a recheck and you're tempted to use a blood pressure cuff that's been hanging on the wall, has not been calibrated in 17 years, has a decaying spiral cord, and looks like it would fall apart if you touched it. Turns out that's probably not the best way to do it, Matt. So, to reiterate: Automated cuffs are the preferred option. They are more accurate. In this episode with Dr Cohen, we talked about making sure we use the appropriate cuff size and when we have patients who have large arms, you may have to use a wrist measurement every so often. In these circumstances, positioning matters: feet flat, back supported, elbow resting on a table, and have two fingers on the opposite clavicle so that everything is at heart level. If you're taking the blood pressure reading using a cuff around the arm itself, again, you should make sure the patient's arm is resting on a tabletop, bedside, or even on your own arm to ensure it's at heart level. You also shouldn't talk with the patient during that process so you can give them every chance to have an accurate blood pressure reading. That's the first thing: Get an accurate reading. Then everything else follows that step, as you should only treat a diagnosis that you've appropriately made. Watto: All the goals are based on a properly taken blood pressure, so if your patient's blood pressure hasn't been appropriately measured, you might overtreat or undertreat someone. For most patients who are nonfrail, we're now shooting for a blood pressure that is below 130/80 mm Hg. The Kidney Disease: Improving Global Outcomes (KDIGO) guidelines for patients with chronic kidney disease state that normal blood pressure should be below 120/80, which is very hard to do. If we're getting people with a systolic in the 120s, that's probably about as good as we're going to get. For treatment, Dr Cohen and I have adopted this practice of using combination pills for hypertension management — either a calcium-channel blocker with an angiotensin-converting enzyme inhibitor or an angiotensin II receptor blocker (ARB). I usually prefer a calcium-channel blocker with an ARB or the 'triple pill,' a single-pill combination of a calcium-channel blocker, an ARB, and a diuretic. That's what I go to now as my first-line agent. I'm using a lot of either low-dose or medium-dose combination therapy. I don't usually go to the highest dose unless I'm in a situation where I have to decide between starting a fourth medication or going to a higher dose. That's really been a practice change for me. Dr Cohen reiterated that point and emphasized that it's easiest for the patient and they usually experience fewer side effects when you choose a low-to-moderate dose in comparison to a high dose. Williams: It's a point that we've made in prior episodes, as well. As you start to max out the doses of these medications, you get diminishing returns in terms of their efficacy in lowering blood pressure efficacy and patients can start to experience increased side effects. It's a far better option to start with a kind of median dose as opposed to really trying to crank up the dose, because you just don't get that much more benefit with that approach. Watto: We're going to discuss some of the newer blood pressure–lowering agents. Paul, the first one I want to ask you about is not quite a blood pressure medication, but it does lower blood pressure. Which medication am I talking about here? Williams: I think you're probably referring to semaglutide, Matt. I think we all have a fair amount of comfort with these diabetes and weight loss medications. These are remarkable medications and the indications keep piling on, which is great. Semaglutide, in particular, is not approved for hypertension, but it does lower blood pressure, likely as a result of the weight loss that is achieved with the medication. So, it's not technically an antihypertensive, but it provides a great blood pressure benefit. I think there's also some 'fancy pants' medications coming down the pipeline that we should probably be aware of, right? Watto: Yes, and the first one I'll mention is endothelin receptor antagonists. As a generalist, you're probably not going to be prescribing these; they will probably be prescribed by a hypertension specialist. Compared with placebo, they have a modest effect in lowering blood pressure (~4 mm Hg), but they are officially approved, so they're out there. What's more exciting, Paul, are aldosterone synthase inhibitors. The generic names for these include baxdrostat and lorundrostat. They're not yet approved, but I believe they are in phase 2 or phase 3 trials, depending on the indications. They seem promising, as they have a much stronger effect on blood pressure (~10-15 mm Hg) compared with placebo. Dr Cohen thinks these medications are probably going to be in the primary care wheelhouse soon. Cost will probably an issue with these medications at the start, but otherwise, these are pills that are taken once a day and they don't have the antiandrogen side effects that you can get with the mineralocorticoid receptor antagonists (MRAs), like spironolactone. Dr Cohen was really excited about being able to prescribe these at some point. Williams: And the MRAs are traditionally a fourth-line medication (unless you have compelling indications), so to have something else in your armamentarium that has less side effects is super exciting. It'll be great to see these in the pipeline. Watto: Now, what would you say, Paul, if I told you there was a medication for blood pressure that is only administered once every 6 months and will shut down the renin-angiotensin-aldosterone system (RAAS)? How does that sound? Williams: As someone who's taken medical school physiology, it sounds lightly terrifying! It feels like you do need the RAAS for some things, but I think for patients that are less interested in taking medications — which turns out to be most patients — it could potentially be exciting. I think as long as we have a way to reverse the effects of this medication if needed, then I think there's potential for excitement around this medication. Watto: I'm of course talking about a small interfering RNA (siRNA) agent. The one we talked about in this episode was zilebesiran; it's an siRNA agent and is administered once every 6 months. But no one would feel comfortable giving this unless there's an antidote, because if a patient gets septic, they probably need their RAAS to help them out there. Williams: Or if you have a patient who is pregnant — lots of reasons why you might actually want that system working. Watto: Exactly. Now, some people just don't want to take medications even if they need them, Paul. What else might be offered to a patient with high blood pressure? And how excited should we be about this next therapy? Williams: I feel like you're asking the wrong guy, Matt! I think you're alluding to renal denervation therapy. I feel it had a lot of wild enthusiasm initially, then it kind of waned, and now I feel like enthusiasm is back, baby — we're back into renal denervation. It sounds like a great option and I think we're doing a little better job with it, but its effect on lowering blood pressure is about equivalent to the effect you observe with a single-agent medication. So, realistically, these patients may still need to be on medications for blood pressure control. It's only effective for about two thirds of patients who get the procedure; that's 33% of your patients who would go through this invasive procedure where we're frying a nerve and in the end, they may not actually experience any blood pressure benefit. I think there's still a population that would benefit from and be interested in this option, but I don't think it's something that we should consider as first-line therapy for the majority of folks because of that potential for treatment failure and the continued need for medications among a substantial portion of the patients who undergo this procedure. It's still exciting that there's evidence for it and it does cause significant blood pressure lowering, so it's nice to have another option. Watto: Yeah, and I think patients are going be coming in and asking about it, so having some knowledge about the pros and cons of the procedure is important.
Yahoo
23-05-2025
- Health
- Yahoo
Everest Medicines Announces NEFECON® Inclusion in China's Clinical Practice Guideline for IgA Nephropathy and IgA Vasculitis in Chinese Adults (For Public Review)
SHANGHAI, May 23, 2025 /PRNewswire/ -- Everest Medicines (HKEX "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing, and commercialization of innovative therapeutics, announced that NEFECON® has been included in the "Clinical Practice Guideline for IgA Nephropathy and IgA Vasculitis in Chinese Adults (For Public Review)" (hereinafter referred to as the "Guideline (Draft)") on May 21, recommending the etiological treatment with a 9-month course of NEFECON® for all primary immunoglobulin A nephropathy (IgAN) patients who are at risk for disease progression, irrespective of proteinuria levels (2B). The Guideline (Draft) was presented by Professor Hong Zhang and Professor Jicheng Lv from Peking University First Hospital, during the IgA Nephropathy Forum and IIgANN-China Annual Meeting. It aims to provide crucial guidance for the standardization and optimization of IgA nephropathy diagnosis and treatment. The Guideline (Draft) emphasizes a new disease management strategy of Treat the cause, Treat early, Treat comprehensively. The Guideline (Draft) recommends that patients with proteinuria ≥ 0.5g/day (or equivalent levels) undergo a renal biopsy and initiate treatment. The treatment goal is to slow the estimated glomerular filtration rate (eGFR) loss to less than 1 ml/min per year. In addition to the two core indicators of proteinuria and eGFR, the Guideline (Draft) also emphasizes routine monitoring of hematuria. For the first time, the guideline introduces interventions targeting immune-mediated injury, particularly the formation of pathogenic IgA (Gd-IgA1), a key driver of pathogenesis to IgAN. For patients at risk of disease progression, the guideline proposes addressing both symptoms of renal function decline, and initiating therapies targeting immune-mediated injury and CKD progression. NEFECON® is recommended as the preferred treatment to reduce Gd-IgA1. Once short-term treatment goals, namely proteinuria remission (defined as proteinuria < 0.5 g/day, ideally < 0.3 g/day) and stable renal function, are achieved, low-dose maintenance or repeated safe and effective immunotherapy can be considered together with supportive care to ensure that eGFR declines by less than 1 ml/min per year. "Compared to European and American populations, China has a large IgAN patient population. Chinese IgAN patients experience more rapid disease progression and poorer prognosis. A majority of IgAN patients face the risk of progressing to end-stage renal disease during their lifetime, placing a heavy burden on patients and society." Said Professor Zhang Hong with Peking University First Hospital, a member of the global steering committee for the Phase 3 clinical trial NefIgArd, chairman of the Chinese Collaborative Group of the International IgAN Federation. "Therefore, IgAN patients require early diagnosis, and a comprehensive treatment approach that spans early intervention, initial therapy, and maintenance therapy. The Guideline (Draft) offers important guidance for clinical practice of IgA nephropathy treatment in China." "IgA nephropathy is the most common form of chronic glomerulonephritis worldwide, affecting 40% to 50%[1,2] of kidney biopsy patients in Asian populations, particularly in China. Fifteen years after diagnosis, the kidney survival rate can drop to as low as 40%[1]. This makes the development of guidelines tailored to the Chinese population particularly important." said Professor Jicheng Lv from Peking University First Hospital. "The Guideline (Draft) updates the treatment strategies and medications for IgAN in China, further standardizing its diagnosis and treatment. It establishes a novel care strategy for Chinese IgAN patients, emphasizing the principles of Treat the cause, Treat early, Treat comprehensively. It recommends treatment with a 9-month course of NEFECON® for IgAN patients at risk of disease progression (2B)." "We are delighted to see NEFECON® included in the Guideline (Draft), marking a milestone that not only provides Chinese physicians a scientific and precise treatment option but also promises greater benefits and improved quality of life for Chinese IgAN patients." said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "As the first and only etiological treatment for IgAN fully approved in China, the United States, and Europe, NEFECON® significantly slows eGFR decline, reduces proteinuria, and preserves kidney function. NEFECON® has established itself as a first-line cornerstone therapy for IgAN. Its inclusion in the draft guideline further validates its outstanding clinical advantages, redefining treatment standards and entering a new era of standardized care." NEFECON®, as the only in-disease IgA nephropathy (IgAN) treatment has been included in the "KDIGO 2024 Clinical Practice Guideline For The Management Of Immunoglobulin A Nephropathy (IgAN) And Immunoglobulin A Vasculitis (IgAV) (public review draft), recommending treatment with a 9-month course of NEFECON® for patients who are at risk of progressive kidney function loss with IgAN (2B). Results from the Phase 3 clinical study NefIgArd of the Chinese population shows that NEFECON® reduces kidney function decline by 66%, and delays disease progression to dialysis or kidney transplantation by 12.8 years. During the 2-year treatment and observation period, NEFECON® also demonstrated clinically significant kidney function protection. With the Phase 3 clinical study and real-world evidence, NEFECON® not only fills the gap in etiological treatment for IgAN both domestically and internationally, but also provides clinicians with more compelling treatment options, giving patients a valuable treatment window. Since May 2025, NEFECON® is indicated to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression, irrespective of proteinuria levels. This approval marks NEFECON® as the first and only etiological treatment for IgA nephropathy (IgAN) to receive full approval in China. NEFECON® was also included in the National Reimbursement Drug List in November 2024. About NEFECON® NEFECON® is a patented oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism. The formulation is designed as a delayed release capsule that is enteric coated so that it remains intact until it releases budesonide to the distal ileum. Each capsule contains coated beads of budesonide that target mucosal B-cells present in the ileum where the disease originates, as per the predominant pathogenesis models. In June 2019, Everest Medicines entered into an exclusive, royalty-bearing license agreement with Calliditas Therapeutics, which gives Everest Medicines exclusive rights to develop and commercialize NEFECON® in mainland China, Hong Kong, Macau, Taiwan (China) and Singapore. The agreement was extended in March 2022 to include South Korea as part of Everest Medicines' territories. About Everest Medicines Everest Medicines is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company's core therapeutic areas of renal diseases, infectious diseases and autoimmune disorders. For more information, please visit its website at Forward-Looking Statements: This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," "confident" and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law. References: 1. Shen X, et al. Nephrol Dial Transplant. 2024 Nov 19: gfae252. 2. Li G, et al. J Nephrol . 2025 Mar 26. doi: 10.1007/s40620-025-02261-1. Online ahead of print. View original content: SOURCE Everest Medicines Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Globe and Mail
16-05-2025
- Health
- Globe and Mail
Anemia in Chronic Kidney Disease Market Set for Significant Growth and Innovation by 2034
Anemia in Chronic Kidney Disease (CKD), a common and debilitating complication resulting from reduced erythropoietin production and iron deficiency, continues to pose serious clinical challenges and an economic burden. DelveInsight's comprehensive report on the Anemia in CKD market sheds light on the evolving understanding and management of this condition, which affects a substantial proportion of patients with moderate to advanced CKD. With improved awareness and screening, earlier diagnosis and intervention are becoming more achievable, especially with the support of emerging biomarkers and treatment guidelines. Innovative therapies such as HIF-PH inhibitors and long-acting erythropoiesis-stimulating agents (ESAs) are shaping a dynamic treatment landscape aimed at improving hemoglobin levels with fewer side effects. DelveInsight's ' Anemia in Chronic Kidney Disease Market Report ' offers an in-depth analysis of the epidemiology, disease burden, and market outlook across key geographies, including the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. The report highlights current unmet needs, late-stage pipeline therapies, market drivers and barriers, and the key players transforming patient care, making it a vital resource for healthcare stakeholders and innovators in nephrology. Some of the Key Facts of the Anemia in Chronic Kidney Disease Market Report: • The anemia in chronic kidney disease is expected to grow at a significant CAGR by 2034. • In 2023, the United States recorded the highest number of prevalent Anemia in Chronic Kidney Disease (CKD) cases among the 7MM. • The U.S. also accounted for the highest number of treated cases of Anemia in CKD during the same year. • A higher prevalence was noted among individuals aged 60 and above compared to those under 60 in the U.S. • Males with CKD had a 30% higher risk of developing anemia compared to females. • Among the EU4 and the UK, Spain reported the lowest number of anemia in CKD cases in 2023. • In Japan, anemia was one of the most frequently documented outcomes, with prevalence rates ranging from 0% to 95%, depending on CKD severity and dialysis status. • In March 2025, the FDA expanded the approval of Furoscix to include the treatment of edema in patients with chronic kidney disease, including nephrotic syndrome. • In March 2025, scPharmaceuticals received FDA approval for a supplemental new drug application (sNDA) for Furoscix (furosemide injection). This approval expands the drug's use to treat edema in patients with chronic kidney disease (CKD), marking a significant advancement in scPharmaceuticals' portfolio for cardiorenal conditions. • In March 2025, the FDA approved an expanded indication for furosemide injection (Furoscix; scPharmaceuticals, Inc.) to treat edema in adult patients with chronic kidney disease (CKD), including nephrotic syndrome. The expanded treatment is expected to be available by April 2025. This approval follows the FDA's acceptance of the supplemental new drug application in July 2024. • In January 2025, the FDA approved a new indication for semaglutide to reduce the risk of worsening kidney disease, kidney failure, and cardiovascular death in adults with type 2 diabetes and chronic kidney disease, according to Novo Nordisk. • In November 2024, Unicycive Therapeutics (Nasdaq: UNCY) announced that the FDA has accepted its New Drug Application (NDA) for Oxylanthanum Carbonate (OLC), with a PDUFA target action date set for June 28, 2025. If approved, OLC has the potential to significantly enhance the treatment of hyperphosphatemia in chronic kidney disease (CKD) patients undergoing dialysis. • Leading companies in the anemia in chronic kidney disease market include Jiangsu HengRui Medicine, Shenyang Sunshine Pharmaceutical, Biocad, Xenetic Biosciences, Chiasma, Liminal BioSciences, Acceleron Pharma, Celgene Corporation, and others. • Emerging therapies in the anemia in chronic kidney disease market include DDO-3055, SSS17, BCD-131, BCD-066, Erythropoietin polysialic, CHIP 2, PBI 1402, Sotatercept, and others. • The rising prevalence of anemia in chronic kidney disease, along with continuous advancements in therapeutic options, is fueling the demand for more effective treatment approaches. To know in detail about the anemia in chronic kidney disease market outlook, drug uptake, treatment scenario, and epidemiology trends, click here: Anemia In Chronic Kidney Disease Market Forecast Anemia in Chronic Kidney Disease Overview Anemia is a frequent and serious complication of Chronic Kidney Disease (CKD), arising as kidney function declines and the body's ability to produce adequate erythropoietin—a hormone essential for red blood cell production, diminishes. CKD impairs the kidneys' filtering ability, leading to the accumulation of waste and fluids, which further contributes to the onset of anemia. The condition becomes increasingly prevalent in advanced stages of CKD. In the United States, over 37 million adults are estimated to have CKD, and more than one in seven individuals with CKD also suffer from anemia. The risk intensifies as kidney function deteriorates, with nearly all individuals at end-stage kidney failure (when kidney function drops below 15%) experiencing anemia. Certain populations are more susceptible: individuals with CKD and diabetes are at higher risk of developing anemia earlier and in more severe forms. Additionally, people over the age of 60 are more likely to be affected. The progression of CKD-related anemia is typically gradual and may remain asymptomatic in its early stages, making early detection and management crucial for improving patient outcomes. Get a free sample of the anemia in chronic kidney disease market report with key insights and emerging therapies here: Anemia in Chronic Kidney Disease Epidemiology The epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2020 to 2034. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. The epidemiology section also provides a detailed analysis of the diagnosed patient pool and future trends. Anemia in Chronic Kidney Disease Epidemiology Segmentation: The anemia in chronic kidney disease epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by: • Total Prevalent Cases of Chronic Kidney Disease • Diagnosed Cases of Anemia in Chronic Kidney Disease • Age-Specific Prevalent Cases of Anemia in Chronic Kidney Disease • Total Prevalent Cases of Anemia in Chronic Kidney Disease • Total Prevalent Cases of Anemia in Different Stages of Chronic Kidney Disease • Treatable Cases of Anemia in Chronic Kidney Disease Download the report to understand which factors are driving anemia in chronic kidney disease epidemiology trends @ Anemia In Chronic Kidney Disease Epidemiology Forecast The anemia in chronic kidney disease drugs uptake section examines the rate at which newly launched or upcoming potential drugs are being adopted in the anemia in chronic kidney disease market during the study period. This analysis covers drug uptake, patient adoption of therapies, and the sales performance of each drug. Additionally, the therapeutics assessment section highlights the drugs with the most rapid uptake, shedding light on the factors driving their widespread use. It also provides a comparative analysis of these drugs based on their market share. The report further delves into the anemia in chronic kidney disease pipeline development activities, offering key insights into various therapeutic candidates in different stages of development and the major companies behind these innovations. It also covers recent collaborations, acquisitions, mergers, licensing agreements, patent details, and other critical information related to emerging therapies. Anemia in Chronic Kidney Disease Market Strengths • The availability of novel oral treatment options, such as daprodustat, offers more convenient and effective routes of administration for patients. • Active research and ongoing clinical trials are enhancing the understanding of the disease and driving innovation in therapeutic strategies. Anemia in Chronic Kidney Disease Market Weaknesses • Patients often struggle to recognize or differentiate the symptoms of anemia from CKD or other related conditions, leading to underreporting. • Healthcare providers, particularly in non-dialysis settings, frequently under-monitor hemoglobin levels and iron stores, resulting in delayed or suboptimal treatment initiation. Scope of the Anemia in Chronic Kidney Disease Market Report • Study Period: 2020–2034 • Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan] • Key Anemia In Chronic Kidney Disease Companies: GlaxoSmithKline, Teva Pharmaceuticals, Cipla, Sun Pharmaceuticals, and others. • Key Anemia In Chronic Kidney Disease Therapies: DDO-3055, SSS17, BCD-131, BCD-066, Erythropoietin polysialic, CHIP 2, PBI 1402, Sotatercept, and others. • Anemia In Chronic Kidney Disease Therapeutic Assessment: Anemia in chronic kidney disease, currently marketed, and anemia in chronic kidney disease emerging therapies • Anemia In Chronic Kidney Disease Market Dynamics: Anemia in chronic kidney disease market drivers and anemia in chronic kidney disease market barriers • Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies • Anemia In Chronic Kidney Disease Unmet Needs, KOL's views, Analyst's views, Anemia In Chronic Kidney Disease Market Access and Reimbursement To learn more about the key players and advancements in the anemia in chronic kidney disease treatment landscape, visit the Table of Contents 1. Anemia In Chronic Kidney Disease Market Report Introduction 2. Executive Summary for Anemia In Chronic Kidney Disease 3. SWOT analysis of Anemia In Chronic Kidney Disease 4. Anemia In Chronic Kidney Disease Patient Share (%) Overview at a Glance 5. Anemia In Chronic Kidney Disease Market Overview at a Glance 6. Anemia In Chronic Kidney Disease Disease Background and Overview 7. Anemia In Chronic Kidney Disease Epidemiology and Patient Population 8. Country-Specific Patient Population of Anemia In Chronic Kidney Disease 9. Anemia In Chronic Kidney Disease Current Treatment and Medical Practices 10. Anemia In Chronic Kidney Disease Unmet Needs 11. Anemia In Chronic Kidney Disease Emerging Therapies 12. Anemia In Chronic Kidney Disease Market Outlook 13. Country-Wise Anemia In Chronic Kidney Disease Market Analysis (2020–2034) 14. Anemia In Chronic Kidney Disease Market Access and Reimbursement of Therapies 15. Anemia In Chronic Kidney Disease Market Drivers 16. Anemia In Chronic Kidney Disease Market Barriers 17. Anemia In Chronic Kidney Disease Appendix 18. Anemia In Chronic Kidney Disease Report Methodology 19. DelveInsight Capabilities 20. Disclaimer 21. About DelveInsight About DelveInsight DelveInsight is a leading Healthcare Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefit from market analysis to accelerate business growth and overcome challenges with a practical approach. Media Contact Company Name: DelveInsight Contact Person: Jatin Vimal Email: Send Email Phone: +14699457679 Address: 304 S. Jones Blvd #2432 City: Las Vegas State: Nevada Country: United States Website:
