PEP Health Unveils the First Real-Time Trust Score for U.S. Healthcare
MINNEAPOLIS, April 29, 2025 /PRNewswire/ - PEP Health, the AI-powered patient experience platform trusted by leading hospitals, payers, and health systems, today announced the launch of its Trust Score, the first real-time, validated metric that quantifies how patients experience and express trust in healthcare.
Built from millions of unsolicited patient narratives and developed alongside a leading U.S. health system, the Trust Score brings long-missing measurement, visibility, and actionability to one of the most critical drivers of health outcomes: patient trust.
Download PEP Health's Trust white paper here.
'In healthcare, trust isn't abstract. It directly impacts outcomes, adherence, and loyalty,' said Dr. Mark Lomax, CEO of PEP Health. 'For the first time, hospitals, payers, and providers can measure trust in real time, pinpoint when and where it erodes, and take immediate steps to rebuild it.'
The Trust Score is already being piloted nationwide, including at ECU Health, a rural health system committed to human-centered care.
'Trust is the foundation of the relationship between healthcare and those they serve. When trust is present in the relationship, patients adhere to treatment plans, seek medical care when needed, and have frank conversations with their care team which is vital to their health planning,' said Dr. Julie Kennedy Oehlert, Chief Experience Officer at ECU Health. 'This trust also fuels the passion and purpose of those that provide care, insulating against burnout.'
More Than a Feeling: Why Trust Now Has a Score
While traditional surveys often struggle with delays, low response rates, and limited reach, PEP Health's Trust Score draws from the real, unprompted voices of patients, capturing their experiences across social media platforms, review sites, and forums. Using advanced machine learning and healthcare-specific natural language processing (NLP) technology, PEP Health analyzes this data into structured insights that reflect the full spectrum of patient experience.
At the core of the Trust Score are Drivers of Trust (such as caring, kindness, effective listening) and Indicators of Trust (such as patient retention and health outcomes)
PEP Health's patient experience insights are validated against national benchmarks including HCAHPS and insurer quality metrics and highlighted in peer-reviewed research published in BMJ Quality & Safety and The Lancet (read more here ).
A Strategic Metric for Today's Healthcare Leaders
Trust is no longer just a value statement: it directly affects health equity, financial performance, and community engagement. Internal PEP Health data shows that a one-point decline in patient satisfaction can result in more than $12 million in annual lost revenue for a large health system.
With the Trust Score, healthcare leaders can now:
'For too long, others have defined what trust should look like in healthcare,' continued Dr. Lomax. 'It's time to listen to patients themselves. When trust breaks down, patients don't show up, don't open up, and don't follow through. Now, for the first time, we can measure trust and take meaningful action to rebuild it.'
Early Access and White Paper
Healthcare leaders can now download PEP Health's new white paper and apply for early access to the Trust Score platform by completing the Early Access request form.
About PEP Health
PEP Health's advanced AI uses healthcare-specific natural language processing (NLP) and machine learning to analyze diverse, unsolicited patient feedback from online sources such as social media, review platforms, and forums, alongside hospital surveys and internal data. By providing a comprehensive, real-time view of patient and community experiences, PEP Health helps healthcare providers gain insights that traditional surveys often miss. This approach enables organizations to understand patient preferences more deeply, focus on what matters most, and align care with evolving expectations.
To learn more, please visit www.pephealth.ai
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Johnson & Johnson seeks first icotrokinra U.S. FDA approval aiming to revolutionize treatment paradigm for adults and adolescents with plaque psoriasis
Icotrokinra is a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor Filing based on unprecedented data package that met all primary endpoints across four Phase 3 studies, including head-to-head superiority comparisons versus deucravacitinib and evaluation of difficult to treat skin sites Submission underscores potential to shift the treatment paradigm for moderate-to-severe plaque psoriasis patients with the standout combination of complete skin clearance, a favorable safety profile, and simplicity of a once daily pill SPRING HOUSE, Pa., July 21, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking the first approval of icotrokinra, a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor for the treatment of adults and pediatric patients 12 years of age and older with moderate to severe plaque psoriasis (PsO). Icotrokinra is uniquely designed to block the IL-23 receptor, which underpins the inflammatory response in plaque PsO and offers potential in other IL-23-mediated diseases.1,2,3 The application included data from four pivotal Phase 3 studies conducted as part of the ICONIC clinical development program, including ICONIC-LEADa, ICONIC-TOTALb and ICONIC-ADVANCE 1 & ICONIC-ADVANCE 2c. Treatment with icotrokinra met all primary and co-primary endpoints across the development program among adults and pediatric patients 12 years of age and older with moderate-to-severe plaque PsO, demonstrating significant skin clearance and a favorable safety profile in a once-daily pill. Results from the ICONIC-ADVANCE 1 & 2 studies show icotrokinra achieved co-primary endpoints and showed superiority to deucravacitinib in moderate-to-severe plaque PsO. Across all studies, pooled safety data showed a similar proportion of patients experienced adverse events (AEs) between icotrokinra (49.1%) and placebo (51.9%) groups, with no new safety signals identified to date.4,5,6,7,8 "The rapid patient enrollment across our ICONIC clinical program underscores the unmet need for an advanced plaque psoriasis treatment that meaningfully addresses their needs and preferences," said Liza O'Dowd, MD, Vice President, Immunodermatology and Respiratory Disease Area Lead, Johnson & Johnson Innovative Medicine. "Given the breadth and depth of our studies, along with the robust clinical results reported to date, we are confident that icotrokinra has the potential to transform how physicians and patients think about plaque psoriasis care, establishing a new standard in the treatment of this immune-mediated disease." Data submitted to the FDA as part of the NDA include: Results from the Phase 3 ICONIC-LEAD study, presented as a late-breaking abstract at the 2025 American Academy of Dermatology (AAD) Annual Meeting, that showed icotrokinra successfully met the co-primary endpoints of Investigator's Global Assessment (IGA)d score of 0/1 (clear or almost clear skin) and Psoriasis Area and Severity Index (PASI)e 90 compared to placebo at Week 16.4 A subgroup analysis of ICONIC-LEAD, presented at the 2025 World Congress of Pediatric Dermatology (WCPD), which demonstrated pediatric patients 12 years of age and older treated with once daily icotrokinra achieved higher rates of clear or almost clear skin at Week 16 compared to patients receiving placebo with no new safety signals identified.5 Data from the Phase 3 ICONIC-TOTAL study, presented at the 2025 Society for Investigative Dermatology (SID) Annual Meeting, that highlighted the potential of icotrokinra in patients with difficult-to-treat scalp and genital psoriasis.6 Results from the Phase 3 ICONIC-ADVANCE 1 & ICONIC-ADVANCE 2 studies, that further reinforced the overall efficacy profile met co-primary endpoints of IGA 0/1 and PASI 90 versus placebo at Week 16. Icotrokinra also met all key secondary endpoints at Weeks 16 and 24 that measured superiority to deucravacitinib in patients with moderate-to-severe plaque PsO.7,8 Comprehensive results are being prepared for presentation at a future medical meeting. Long-term data from the ICONIC development program, including at least 52-weeks of treatment for ICONIC-LEAD and ICONIC-TOTAL, and results from a randomized withdrawal analysis evaluating the durability of response, are being prepared for presentation at a future medical meeting. Johnson & Johnson has also initiated the Phase 3 ICONIC-ASCENDf study, the first-ever head-to-head study seeking to demonstrate the superiority of an oral pill, icotrokinra, compared to an injectable biologic, ustekinumab, representing an important step forward in psoriasis research.9 Editor's notes: a. ICONIC-LEAD is a Phase 3 randomized controlled trial (RCT) evaluating the efficacy and safety of icotrokinra compared with placebo in 684 participants (icotrokinra=456; placebo=228) 12 years of age or older with moderate-to-severe plaque PsO, with the higher efficacy bar of PASI 90 and IGA score of 0/1 with at least a 2-grade improvement as co-primary endpoints. ICONIC-LEAD enrolled 66 adolescent patients. b. ICONIC-TOTAL is a Phase 3 RCT evaluating the efficacy and safety of icotrokinra compared with placebo for the treatment of plaque PsO in 311 participants (icotrokinra=208; placebo=103) with at least moderate severity affecting special areas (e.g., scalp, genital and/or hands and feet) with overall IGA score of 0 or 1 with at least a 2-grade improvement as the primary endpoint. c. ICONIC- ADVANCE 1 & 2 are Phase 3 RCTs evaluating the efficacy and safety of icotrokinra compared with placebo and deucravacitinib in participants with moderate-to-severe plaque PsO with PASI 90 and IGA score of 0/1 with at least a 2-grade improvement as co-primary endpoints. d. The IGA is a five-point scale with a severity score ranging from 0 to 4, where 0 indicates clear, 1 is minimal, 2 is mild, 3 is moderate and 4 indicates severe disease.10 e. The PASI score grades the amount of surface area on each body region that is covered by psoriasis plaques and the severity of plaques for their redness, thickness and scaliness.11 PASI 90 corresponds to an improvement of >=90% in PASI score from baseline.11 f. ICONIC-ASCEND is a Phase 3 RCT and the first-ever head-to-head study seeking to demonstrate the superiority of an oral pill, icotrokinra, compared to an injectable biologic, ustekinumab in moderate-to-severe plaque PsO.9 About the ICONIC Clinical Development Program The pivotal Phase 3 ICONIC clinical development program of icotrokinra (JNJ-2113) in adult and adolescent individuals with moderate-to-severe plaque PsO was initiated with two studies in Q4 2023 – ICONIC-LEAD and ICONIC-TOTAL – pursuant to the license and collaboration agreement between Protagonist Therapeutics, Inc. and Janssen Biotech, Inc., a Johnson & Johson company.12 ICONIC-LEAD (NCT06095115) is a RCT to evaluate the efficacy and safety of icotrokinra compared with placebo in participants with moderate-to-severe plaque PsO, with PASI 90 and IGA score of 0 or 1 with at least a 2-grade improvement as co-primary endpoints.13 ICONIC-TOTAL (NCT06095102) is a RCT to evaluate the efficacy and safety of icotrokinra compared with placebo for the treatment of PsO in participants with at least moderate severity affecting special areas (e.g., scalp, genital, and/or hands and feet) with overall IGA score of 0 or 1 with at least a 2-grade improvement as the primary endpoint.14 Other Phase 3 studies in the development program include ICONIC-ADVANCE 1 (NCT06143878) and ICONIC-ADVANCE 2 (NCT06220604), which are evaluating the efficacy and safety of icotrokinra compared with both placebo and deucravacitinib in adults with moderate-to-severe plaque PsO.15,16 ICONIC-ASCEND will evaluate the efficacy and safety of icotrokinra compared with placebo and ustekinumab in participants with moderate-to-severe plaque psoriasis. ICONIC-PsA 1 (NCT06878404) and ICONIC-PsA 2 (NCT06807424) will evaluate the efficacy and safety of icotrokinra compared to placebo in participants with active psoriatic arthritis.17,18 About Plaque Psoriasis Plaque psoriasis (PsO) is a chronic immune-mediated disease resulting in overproduction of skin cells, which causes inflamed, scaly plaques that may be itchy or painful.19 It is estimated that 8 million Americans and more than 125 million people worldwide live with the disease.20 Nearly one-quarter of all people with plaque PsO have cases that are considered moderate-to-severe.20 Plaques typically appear as raised patches with a silvery white buildup of dead skin cells or scales. Plaques may appear red in lighter skin or more of a purple, gray or dark brown color in patients with darker skin tones. Plaques can appear anywhere on the body, although they most often appear on the scalp, knees, elbows, and torso.21 Living with plaque PsO can be a challenge and impact life beyond a person's physical health, including emotional health, relationships, and handling the stressors of life.22 Psoriasis on highly visible areas of the body or sensitive skin, such as the scalp, hands, feet, and genitals, can have an increased negative impact on quality of life.22,23 About Icotrokinra (JNJ-77242113, JNJ-2113) Investigational icotrokinra is the first targeted oral peptide designed to selectively block the IL-23 receptor,1 which underpins the inflammatory response in moderate-to-severe plaque PsO, ulcerative colitis and offers potential in other IL-23-mediated diseases.2,3 Icotrokinra binds to the IL-23 receptor with single-digit picomolar affinity and demonstrated potent, selective inhibition of IL-23 signaling in human T cells.24 The license and collaboration agreement established between Protagonist Therapeutics, Inc. and Janssen Biotech, Inc., a Johnson & Johnson company, in 2017 enabled the companies to work together to discover and develop next-generation compounds that ultimately led to icotrokinra.25 Icotrokinra was jointly discovered and is being developed pursuant to the license and collaboration agreement between Protagonist and Johnson & Johnson. Johnson & Johnson retains exclusive worldwide rights to develop icotrokinra in Phase 2 clinical trials and beyond, and to commercialize compounds derived from the research conducted pursuant to the agreement against a broad range of indications.26,27,28 Icotrokinra is being studied in the pivotal Phase 3 ICONIC clinical development program in moderate-to-severe plaque psoriasis, including ICONIC-ASCEND; the ICONIC-PSA 1 and ICONIC-PSA 2 studies in active psoriatic arthritis; and the Phase 2b ANTHEM-UC study in moderately to severely active ulcerative colitis. About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at or at Follow us at @JNJInnovMed. Janssen Research & Development, LLC and Janssen Biotech, Inc. are Johnson & Johnson companies. Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding icotrokinra (JNJ-2113). The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. 1 Bissonnette R, et al. Data presentation. A phase 2, randomized, placebo-controlled, dose-ranging study of oral JNJ-77242113 for the treatment of moderate-to-severe plaque psoriasis: FRONTIER 1. Presented at WCD 2023, July 3-8.2 Razawy W, et al. The role of IL‐23 receptor signaling in inflammation‐mediated erosive autoimmune arthritis and bone remodeling. Eur J Immunol. 2018 Feb; 48(2): 220–229.3 Tang C, et al. Interleukin-23: as a drug target for autoimmune inflammatory diseases. Immunology. 2012 Feb; 135(2): 112–124.4 Bissonnette, R et al. Icotrokinra, a Targeted Oral Peptide That Selectively Blocks the Interleukin-23–Receptor, for the Treatment of Moderate-to-Severe Plaque Psoriasis: Results Through Week 24 of the Phase 3, Randomized, Double-blind, Placebo-Controlled ICONIC-LEAD Trial. Late-breaking research presentation (Abstract #66708) at the American Academy of Dermatology (AAD) 2024 Annual Meeting. March 2025.5 Eichenfield, L et al. Efficacy and Safety of Icotrokinra, a Novel Targeted Oral Peptide (IL-23R-inhibitor), in Adolescents With Moderate-to- Severe Plaque Psoriasis: Subgroup Analyses From a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study (ICONIC-LEAD). Presented at the World Congress of Pediatric Dermatology (Abstract #0054). April 2025.6 Gooderham, M.J. et al. Phase 3 results from an innovative trial design of treating plaque psoriasis involving difficult-to-treat, high-impact sites with icotrokinra, a targeted oral peptide that selectively inhibits the IL-23–receptor. Presented at the 2025 Society for Investigative Dermatology (Abstract #LB1142). May 2025.7 Data on file.8 Data on file.9 A Study to Assess Efficacy and Safety of JNJ-77242113 Compared to Placebo and Ustekinumab in Participants With Moderate to Severe Plaque Psoriasis (ICONIC-ASCEND). Identifier NCT0693422. Accessed July 2025.10 Simpson E, Bissonnette R, Eichenfield LF, et al. The validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™): The development and reliability testing of a novel clinical outcome measurement instrument for the severity of atopic dermatitis [published online April 25, 2020]. J Am Acad Dermatol. doi: 10.1016/ Accessed July 2025.11 Thompson Jr, D. How the Psoriasis Area and Severity Index works. Everyday Health. Available at: Accessed July 2025.12 Protagonist Therapeutics. Press release. Protagonist announces advancement of JNJ-2113 across multiple indications. Available at: Accessed July 2025.13 A study of JNJ-2113 in adolescent and adult participants with moderate-to-severe plaque psoriasis (ICONIC-LEAD). Identifier NCT06095115. Accessed July 2025.14 A study of JNJ-2113 for the treatment of participants with plaque psoriasis involving special areas (scalp, genital, and/or palms of the hands and the soles of the feet) (ICONIC-TOTAL). Identifier NCT06095102. Accessed July 2025.15 A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis. Identifier NCT06143878. Accessed July 2025.16 A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis (ICONIC-ADVANCE 2). Identifier NCT06220604. Accessed July 2025.17 A Study to Evaluate the Efficacy and Safety of JNJ-77242113 (Icotrokinra) in Biologic-naïve Participants With Active Psoriatic Arthritis (ICONIC-PsA 1). Identifier NCT06878404. A Study to Evaluate the Efficacy and Safety of Icotrokinra (JNJ-77242113) in Biologic-experienced Participants With Active Psoriatic Arthritis (ICONIC-PsA 2). Identifier NCT06807424. National Psoriasis Foundation. About Psoriasis. Available at: Accessed July 2025.20 National Psoriasis Foundation. Psoriasis Statistics. Available at: Accessed July 2025.21 National Psoriasis Foundation. Plaque Psoriasis. Available at: Accessed July 2025.22 National Psoriasis Foundation. Life with Psoriasis. Available at: Accessed July 2025.23 National Psoriasis Foundation. High Impact Sites. Available at: Accessed July 2025.24 Pinter A, et al. Data Presentation. JNJ-77242113 Treatment Induces a Strong Systemic Pharmacodynamic Response Versus Placebo in Serum Samples of Patients with Plaque Psoriasis: Results from the Phase 2, FRONTIER 1 Study. Presented at EADV 2023, October 11-14.25 Johnson & Johnson. Press release. Janssen enters into worldwide exclusive license and collaboration agreement with Protagonist Therapeutics, Inc. for the oral Interlukin-23 receptor antagonist drug candidate for the treatment of Inflammatory Bowel Disease. Available at: Accessed July 2025.26 Protagonist Therapeutics. Press release. Protagonist Therapeutics announces amendment of agreement with Janssen Biotech for the continued development and commercialization of IL-23 antagonists. Available at: Accessed July 2025.27 Protagonist Therapeutics. Press release. Protagonist Reports positive results from Phase 1 and pre-clinical studies of oral Interleukin-23 receptor antagonist JNJ-2113. Available at: Accessed July 2025.28 Protagonist Therapeutics. Press release. Protagonist Therapeutics announces positive topline results for Phase 2b FRONTIER 1 clinical trial of oral IL-23 receptor antagonist JNJ-2113 (PN-235) in psoriasis. Available at: Accessed July 2025. Media contact: Meg Farina mfarina@ Investor contact: Lauren Johnson investor-relations@ View original content to download multimedia: SOURCE Johnson & Johnson Sign in to access your portfolio
Yahoo
16 hours ago
- Yahoo
Medunik USA expands Siklos® (hydroxyurea) coverage under Medicaid Programs to 37 states
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This medicine is the only hydroxyurea (HU)-based therapeutic option that offers both flexible dosing and administration, giving patients and caregivers more control over managing their care and shaping a treatment routine that works for them. Patients can choose the best way to take Siklos®, whether by swallowing it whole or split based on the dose, or dissolving it in a small amount of water. Siklos® is the only FDA-approved dissolvable formulation of hydroxyurea that reduces painful crises and blood transfusions for sickle cell patients aged 2 years and older. Siklos® has a BOXED WARNING regarding Low Blood Cell Count and Cancer. The most common side effects of Siklos® in children include: infections and low white blood cells, and in adults include: infections, headache, and dry skin. "We are proud to see increased coverage for this important therapy, which represents a significant step forward in the standard of care for patients with sickle cell disease. Siklos® provides patients with options on how to best take their HU treatment," said Tanya Carro, Executive Vice President, U.S. Entities. "With fewer SCD treatment options currently available, it is even more important to empower patients to stay on therapy in a way that fits their lives. That's what drives long-term adherence and meaningful health outcomes." Sickle cell anemia is the most common inherited blood disorder, resulting in the production of abnormal hemoglobin, known as hemoglobin-S, responsible for the sickling of red blood cells. This disease affects nearly 100,000 Americans, decreases life expectancy by 25 to 30 years, induces significant morbidity and, may therefore, reduce quality of life1,2. Most of those affected are of African ancestry; a minority are of Hispanic or southern European, Middle Eastern or Asian Indian descent3. Committed to improving the lives of people living with rare disorders, Medunik USA strives to remove the logistical barriers and to broaden reimbursement pathways to empower patients with SCD and their caregivers. Medunik USA supports patient access by offering a robust assistance program that includes educational resources and savings programs. For more information please visit: . INDICATION AND IMPORTANT SAFETY INFORMATION SIKLOS is a prescription medicine that is used to reduce the frequency of painful crises and reduce the need for blood transfusions in adults and children, 2 years of age and older, with sickle cell anemia with recurrent moderate to severe painful crises. It is not known if SIKLOS is safe and effective in children less than 2 years of age. IMPORTANT SAFETY INFORMATION BOXED WARNING: LOW BLOOD CELL COUNT and CANCERSee Full Prescribing Information for complete Boxed Warning. Low blood cell counts are common with SIKLOS, including low red blood cells, white blood cells, and platelets, and can be severe and life threatening. If your white blood cell count becomes very low, you are at increased risk for infection. Your healthcare provider will check your blood cell counts before and every 2 weeks during treatment with SIKLOS. Your healthcare provider may change your dose or tell you to stop taking SIKLOS if you have low blood cell counts. Tell your healthcare provider right away if you get any of the following symptoms: fever or chills; shortness of breath; body aches; unusual headache; feeling very tired; bleeding or unexplained bruising. Cancer. Some people have developed cancer, such as leukemia and skin cancer, after taking SIKLOS for a long time. Your healthcare provider will check you for cancer. You should protect your skin from the sun using sunblock, hats, and sun-protective clothing. WHAT IS THE MOST IMPORTANT INFORMATION YOU SHOULD KNOW ABOUT SIKLOS? SIKLOS can harm your unborn baby. For females taking SIKLOS who can become pregnant: You should talk with your healthcare provider about the risks of SIKLOS to your unborn baby. You should use effective birth control during treatment with SIKLOS and for at least 6 months after treatment with SIKLOS. Your healthcare provider will perform a pregnancy test before you start treatment with SIKLOS. Tell your healthcare provider right away if you become pregnant or think you may be pregnant. For males taking SIKLOS: SIKLOS can affect your sperm. If you have a female sexual partner who can become pregnant, you should use effective birth control during treatment with SIKLOS and for at least 6 months after treatment. SIKLOS may cause fertility problems in males. Talk to your healthcare provider if this is a concern for you. WHO SHOULD NOT TAKE SIKLOSDo not take SIKLOS if you are allergic to hydroxyurea or any of the ingredients in SIKLOS. See the Medication Guide for a list of the ingredients in SIKLOS. WHAT SHOULD YOU TELL YOUR HEALTH CARE PROVIDER BEFORE TAKING SIKLOS?Tell your healthcare provider about all of your medical conditions, including if you: have kidney problems or are receiving hemodialysis have liver problems have human immunodeficiency virus (HIV) or take HIV medicines. Taking SIKLOS with certain HIV medicines can cause serious reactions and may lead to death. have increased levels of uric acid in your blood (hyperuricemia) have a history of receiving interferon therapy or are currently receiving interferon therapy have leg wounds or ulcers plan to receive any vaccinations. You should not receive "live vaccines" during treatment with SIKLOS. are pregnant or plan to become pregnant. See "What is the most important information I should know about SIKLOS?" are breastfeeding or plan to breastfeed. It is not known if SIKLOS can pass into your breast milk. Do not breastfeed during treatment with SIKLOS. are using a continuous glucose monitor (CGM) to test your blood glucose. Talk to the healthcare provider that prescribed your CGM about whether it is safe to use while you are taking SIKLOS. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. WHAT ARE THE POSSIBLE SIDE EFFECTS OF SIKLOS?SIKLOS may cause serious side effects, including: See "What is the most important information I should know about SIKLOS?" Skin ulcers, including leg ulcers, and death of skin tissue (gangrene) have happened in people who take SIKLOS. This has happened most often in people who receive interferon therapy or have a history of interferon therapy. Your healthcare provider will decrease your dose or stop treatment with SIKLOS if you develop any skin ulcers. Enlarged red blood cells (macrocytosis). Macrocytosis is common in people who take SIKLOS and can make it difficult to detect a decrease of folic acid. Your healthcare provider may prescribe a folic acid supplement for you. Hemolytic Anemia, the fast breakdown of red blood cells, has happened in people who take SIKLOS. Tell your healthcare provider I you develop yellowing of your skin (jaundice) or blood in your urine. Your healthcare provider may do blood tests if you have persistent or worsening anemia not related to sickle cell anemia. The most common side effects of SIKLOS in children include: infections and low white blood cells. The most common side effects of SIKLOS in adults include: infections, headache, and dry skin. These are not all the possible side effects of SIKLOS. You are encouraged to report negative side effects of prescription drugs to the FDA at or 1-800-FDA-1088. Please read the Full Prescribing Information, including Boxed Warning, Medication Guide and Instructions for Use, at ABOUT MEDUNIK USA Based in Princeton, New Jersey, Medunik USA is part of Duchesnay Pharmaceutical Group and works to improve the health and quality of life of Americans living with rare diseases by making orphan drug therapies available in the United States. Through its strategic partnerships, Medunik USA develops and provides Americans suffering from rare disease with access to orphan drugs that are not currently available in the U.S. Medunik USA makes critical medications to treat rare diseases available to American patients who might not otherwise have access to these medications. For more information about Medunik USA, please visit Follow us on LinkedIn. ABOUT DUCHESNAY PHARMACEUTICAL GROUP Duchesnay Pharmaceutical Group (DPG), with its affiliated companies, is headquartered in Blainville, Quebec. The Group consists of six pharmaceutical companies to meet the needs of patients in Canada, the U.S. and abroad. The companies are Duchesnay (Canada) and Duchesnay USA, both dedicated to women's health; Medunik Canada and Medunik USA, which provide treatments for rare and debilitating diseases; and Analog Pharma Canada and Analog Pharma, specializing in orphan generic medications. From its state-of-the-art manufacturing plant, DPG exports its innovative treatments to more than 50 countries. DPG is one of the eight companies across the country chosen to participate in the Government of Canada's Global Hypergrowth Project. This appointment offers exclusive and personalized support for at least two years, in order to accelerate its growth to become an anchor firm in the Canadian economy. DPG is the winner of the 2024 Life Sciences Innovation Award by ADRIQ, the Association for the Development of Research and Innovation of Quebec, which recognizes DPG's healthy workplace culture and commitment to pharmaceutical innovation, while DPG president Éric Gervais is the recipient of the 2024 Bernard-Landry Award by ADRIQ which acknowledges his impactful leadership on Quebec's research and innovation ecosystem. DPG, through its proprietary research and development, and through exclusive partnerships, offers innovative treatments for a variety of medical conditions in women's health, urology, oncology and for rare diseases, plus lower-cost generic medications. DPG recognizes the dedication and professionalism of its employees and promotes a positive culture and flexible work environment. It is deeply committed to environmental responsibility and to giving back to the community through the support of various charitable organizations. For more information, please visit Follow us on LinkedIn. References: 1. Platt OS et al. Mortality in sickle cell disease. Life expectancy and risk factors for early death. The New England Journal of Medicine 330, 1639-1644, doi:10.1056/NEJM199406093302303 (1994). 2. McGann PT and Ware RE, Hydroxyurea therapy for sickle cell anemia. Expert opinion on drug safety 14, 1749-1758, doi:10.1517/14740338.2015.1088827 (2015). 3. National Heart, Lung, and Blood Institute, National Institutes of Health, Sickle Cell Disease, View original content to download multimedia: SOURCE Medunik USA Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
Yahoo
a day ago
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Precision Era to Redefine Treatment, Drive $450B Economic Investment and Change Lives Across Asia Pacific
SINGAPORE, July 22, 2025 /PRNewswire/ -- The Precision Era of medicine is arriving in Asia Pacific, driven by the arrival of a critical mass of innovative therapies that will redefine treatment, attract investment and improve lives, a new expert-driven report finds. Released today, 'On the Cusp of a Cure' White Paper examines Asia Pacific's readiness for the Precision Era – the current, transformative period where generically prescribed and regularly administered treatments are increasingly giving way to potentially curative therapies tailored to individuals and their disease. Treatments called precision therapies. Across the four markets over the next 10 years, the new research by L.E.K. Consulting and an advisory committee of 16 Asia Pacific experts using a proprietary 'whole system benefits modelling' approach found that the Precision Era has the potential to: Drive direct economic investment of approximately USD 450 billion.[i] Create almost 1.2 million highly skilled jobs[i] in R&D, advanced manufacturing and biotechnology. Drive USD1.615 trillion in broader[i], indirect economic benefit via a multiplier effect across adjacent industries. Save healthcare systems across the four markets USD 39 billion[i], alleviating intense pressure on resources. Increase workforce participation for 24 million patients and caregivers by improving their ability to return or stay in work.[i] "The Precision Era is being driven by the arrival of a critical mass of some 4,000 innovative cell and gene therapies that will redefine treatment, attract investment and improve lives. Never before have we had such a clear view of the huge potential that this new era holds for Asia-Pacific. Healthcare systems stand to save billions, and patients could potentially live healthier for longer. The broader economic impact of this new era medicine is equivalent to South Korea's annual GDP, and the potential for new jobs greater than the entire population of Adelaide," said Stephanie Newey, Managing Partner, Head of L.E.K. Consulting Australia. Precision therapies put us on the cusp of a cure The 'On the Cusp of a Cure' research assessed data from more than 1,000 clinical trials across four novel technologies – gene therapies, targeted antibody therapies, drug-device combination therapies, and diagnostic technologies. These precision therapies are considered part of the Precision Era because they provide enhanced health benefits through a more tailored approach, represent a paradigm shift to how care has been provided previously and are the focus of significant research and investment. Critically, some experts suggest we may be on the cusp of a cure for diseases that have previously been considered incurable and represent Asia-Pacific's most pressing health challenges, such as many cancers and genetic disorders. "Asia disproportionately carries the largest cancer and rare disease burden in the world. It shoulders nearly half of all global cancer incidence[ii] and is home to 258 million people who are living with rare diseases[iii]. Worse still, these numbers are only expected to grow, fuelling calls for sustainable, scalable and effective solutions. Precision therapies are stepping forward to meet this critical need and represent a new standard of care for many of Asia-Pacific's health challenges," said Professor Baorong Yu, from the University of International Business and Economics in China. One of the most groundbreaking examples of these treatments is chimeric antigen receptor T-cell (CAR-T) therapy that modifies the body's own T cells (a type of white blood cell) to target and destroy cancer cells[iv]. It is commonly used in the treatment of blood cancers, which has a 50% survival rate for over a third of patients. Currently, these patients are mostly treated through chemotherapy and radiotherapy, but many do not respond or will relapse. "With increased access to innovative treatments such as CAR-T therapy, particularly earlier in treatment regimes, patients could live longer with a better quality of life," said Naomi Sakurai, Advisory Committee member and Founder and CEO, Cancer Solutions. "Rather than going through multiple rounds of chemo, they would have a therapy tailored specifically to their condition. These precision treatments are now offering hope by potentially curing once-incurable diseases and giving people the priceless gift of more time with their loved ones." What's holding back the adoption of precision therapies? The Precision Era brings fundamental change to the way disease is approached and how patients are treated, and requires an equivalent rethink from regulators and policymakers. While each market has its own, unique policy environment, 'On the Cusp of a Cure' series found that Australia, China, Japan, and South Korea all exhibit similar barriers to precision therapy adoption. Rules remain unclear for evaluating the reimbursement of new precision therapies, there is limited awareness among patients and doctors about these treatments, and better healthcare infrastructure is needed to support access. The 'On the Cusp of a Cure' research presents a number of regional solutions to unlock the potential benefits of precision therapies: Establish streamlined regulatory and reimbursement pathways specifically tailored for these treatments Increase education for providers, patients, and the community to enhance understanding of the Precision Era Enhance public-private collaboration to foster innovation and equitable access to precision therapies. Improve access and affordability through pricing strategies, reimbursement frameworks, and insurance initiatives for treatments and diagnostics alike. Through clinical guidelines and knowledge sharing, empower HCPs to make informed decisions about precision therapies, and assist patients in complex treatment paths. By backing local industry investments in therapies and diagnostics, and nurturing expertise, joint efforts can drive sustainable progress towards transformative innovations. "With this new era of precision therapies, we stand at the threshold of transforming healthcare across Asia-Pacific," said Sakurai. "But for the full potential of these medicines to materialise, regulatory systems as well as knowledge and infrastructure must keep up. The goal of precision therapies is to ensure the right patient, right timing, right treatment and right dose. We all have a role to play, including policymakers, healthcare professionals, and healthcare industry leaders, to remove barriers for patients to these potentially life-changing therapies." "On the Cusp of a Cure White Paper Asia Pacific Series is made up of four local market white papers evaluating barriers to precision therapy adoption, providing recommendations for improvement, and assessing the value of widespread adoption in Australia, China, Japan, and Korea. Notes to Editor: On the Cusp of a Cure White Paper Series and Advisory Committee Members The On the Cusp of a Cure whitepaper series was supported by an advisory committee of 16 pre-eminent regional experts in precision medicine, economic and health policy, and patient experience across Australia, China, Japan and Korea. It was also sponsored by Johnson & Johnson. Australia China South Korea Japan David Thomas, Chief Scientific Officer, Omico Jaala Pulford, Chair of the Board, MTPConnect Christine Cockburn, CEO, Rare Cancers Australia Baorong Yu, Professor and market access key opinion leader, University of International Business and Economics Andy Mok, Head of China, Guardant Health Kevin Huang, Founder and president, China Organization for Rare Disorders (CORD) Caicun Zhou, Professor and lung cancer key opinion leader, School of Medicine, Tongji University Paul Lee, Former GM, Gilead Sciences Korea Jin-Ah Kim, Advocate for rare diseases, Seoul National University Hospital, Department of Genomic Medicine, Rare Disease Centre Prof Jeonghoon Ahn, Professor of Health Convergence, Ewha University Teruyuki Katori, Representative Director, Special Appointed Professor, Future Institute Wolong, General Incorporated Association Graduate School of Social Sciences, University of Hyogo Daisuke Sato, Professor. Fujita Health university Manabu Muto, Professor, Kyoto University Graduate School of Medicine Masahiro Miyake, Professor, Kyoto University Hospital Naomi Sakurai, Founder and CEO, Cancer Solutions Keisuke Shimizu, Leader, Lung cancer HER2 "HER HER" About L.E.K. Consulting We're L.E.K. Consulting, a global strategy consultancy working with business leaders to seize competitive advantage and amplify growth. Our insights are catalysts that reshape the trajectory of our clients' businesses, uncovering opportunities and empowering them to master their moments of truth. Since 1983, our worldwide practice — spanning the Americas, Europe, Middle East and Asia-Pacific — has guided leaders across all industries from global corporations to emerging entrepreneurial businesses and private equity investors. Looking for more? Visit [i] L.E.K Consulting. On the Cusp of a Cure 2025. [ii] Huang J, Ngai CH, Deng Y, Tin MS, Lok V, Zhang L, Yuan J, Xu W, Zheng ZJ, Wong MCS. Cancer Incidence and Mortality in Asian Countries: A Trend Analysis. Cancer Control. 2022 Jan-Dec;29:10732748221095955. doi: 10.1177/10732748221095955. PMID: 35770775; PMCID: PMC9252010. [iii] IQVIA. Rare Diseases in APAC: The Unmet Potential. Available from Accessed April 2025. [iv] American Cancer Society. CAR T-cell therapy and Its Side-effects. Available from View original content: SOURCE L.E.K Consulting
