Latest news with #Cosentyx
Yahoo
8 hours ago
- Health
- Yahoo
Novartis' Cosentyx shows no benefit in Phase III GCA trial
Novartis' Cosentyx (secukinumab) has failed to show any benefit in the Phase III study in adults with newly diagnosed or relapsing giant cell arteritis (GCA). In the GCAptAIN trial (NCT04930094), Cosentyx was evaluated in combination with a 26-week steroid taper and compared to a placebo plus a 52-week steroid taper. Cosentyx did not demonstrate a statistically significant improvement in sustained remission at week 52 compared to placebo, the study's primary endpoint. There was also no statistical improvement in secondary endpoints, but Novartis did state that patients treated with Cosentyx showed numerically better outcomes compared to placebo for cumulative steroid dose and steroid-related toxicity. Safety remained consistent with previous studies and real-world data of Cosentyx patients. The randomised, double-blind, placebo-controlled study enrolled 354 patients from 27 countries. Novartis' chief medical officer Dr Shreeram Aradhye, said: "While the Phase III results of GCAptAIN did not replicate the positive outcomes observed in the Phase II trial, we remain committed to continuing to drive scientific progress and deepening the understanding of immune-mediated diseases.' Novartis will complete a full evaluation of the GCAptAIN data, with the findings shared at a future date. Currently, treatment includes corticosteroids, usually prednisone, as a first-line treatment. Patients may also be treated with Actemra (tocilizumab), an IL-6 receptor antagonist. There are a number of candidates in mid-stage and late-stage studies, including BMS' Orencia (abatacept), which is in a Phase III trial in GCA. Novartis' Cosentyx is a fully human biologic that directly inhibits interleukin-17A. It acts by neutralising IL-17A, which reduces inflammation associated with autoimmune and inflammatory conditions. It was first approved by the US Food and Drug Administration (FDA) in January 2015 for the treatment of moderate-to-severe plaque psoriasis in adults. It has since been approved for use in children aged six years and over with plaque psoriasis, adults with hidradenitis suppurativa (HS), and adults with active psoriatic arthritis (PsA), among others. GlobalData analysis suggests Cosentyx will make peak annual sales of $8.2bn in 2028 before sales start to drop. This will be largely related to the US drug expiry for Cosentyx in January 2029, allowing generic versions of the therapy to enter the market. GlobalData is the parent company of Clinical Trials Arena. "Novartis' Cosentyx shows no benefit in Phase III GCA trial" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. 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
Bloomberg
2 days ago
- Health
- Bloomberg
Novartis Blockbuster Antibody Drug Fails in Late-Stage Trial
Novartis AG 's drug Cosentyx failed in a late-stage study of patients suffering from inflammation in their blood vessels, a blow to the Swiss company's efforts to find new uses for the blockbuster medicine. The therapy, already one of Novartis's top sellers, did not demonstrate statistically significant improvement in adult patients suffering from giant cell arteritis, an ailment that can cause loss of vision and life-threatening aneurysms, according to a statement Thursday. The drug was compared with placebo, with all trial participants also getting a steroid.
Reuters
2 days ago
- Health
- Reuters
Novartis drug Cosentyx fails late-stage trial for artery disease
ZURICH, July 3 (Reuters) - Novartis (NOVN.S), opens new tab said on Thursday that its Cosentyx drug had failed in a late-stage trial on adults with giant cell arteritis (GCA), a condition characterised by inflammation of the arteries. The drug failed to show an improvement in sustained remission among patients with newly diagnosed or relapsing GCA, a condition that affects people aged mainly over 50 and can cause vision loss and life threatening aneurysms, Novartis said. "While the Phase III results... did not replicate the positive outcomes observed in the Phase II trial, we remain committed to continuing to drive scientific progress and deepening the understanding of immune-mediated diseases," said Shreeram Aradhye, president of development and chief medical officer at the company.
Associated Press
02-06-2025
- Business
- Associated Press
Access Barriers Hamper Early Line Adoption of UCB's Bimzelx at Six Months Post-Launch in Psoriatic Arthritis and Axial Spondyloarthritis, According to Spherix Global Insights
EXTON, PA, June 02, 2025 (GLOBE NEWSWIRE) -- Just over six months into its dual launch across Psoriatic Arthritis (PsA) and Axial Spondyloarthritis (axSpA), UCB's Bimzelx (bimekizumab) is demonstrating meaningful promise, though prescriber momentum remains tempered by access hurdles and payer-imposed constraints, according to new findings from Spherix Global Insights' Launch Dynamix™ services. Physicians across both PsA (n=76) and axSpA (n=73) have expressed strong clinical enthusiasm for Bimzelx, particularly citing its unique dual inhibition of IL-17A and IL-17F as a differentiator from existing IL-17 agents. In PsA, rheumatologists report confidence in the drug's performance across both skin and joint domains and consider it a therapeutic advance over competitors like Novartis' Cosentyx and Eli Lilly's Taltz. In axSpA, particularly among more severe or refractory patients, Bimzelx is increasingly viewed as a preferred IL-17, with some physicians already positioning it ahead of established options in terms of anticipated efficacy and breadth of benefit. Despite its favorable clinical profile, Bimzelx's adoption is constrained by a consistently challenging reimbursement environment. In PsA, nearly all prescriptions require prior authorization, with step therapy requirements and payer preferences for legacy agents continuing to block earlier use. These access challenges are echoed in AS and nr-axSpA, where physicians cite not only high out-of-pocket costs and Medicare limitations but also a general lack of formulary inclusion across plans. While some rheumatologists note success in early line use, many describe regular denials and delays that often force them to default to more accessible agents despite clinical preference for Bimzelx. As one rheumatologist summarizes, 'I like Bimzelx. The big headwind I'm facing now, it just gets denied by insurers. So commercial insurance coverage, which seems to always plague UCB products, is horrible. I'm hoping that will improve.' To address these access barriers, some physicians are turning to samples and bridge programs. However, in PsA, just 13% of patients initiated on Bimzelx started with a sample or free drug, with a pattern similarly observed in axSpA. While sampling and bridge programs are providing a critical means to initiate Bimzelx, physician sentiments support that these are often used to navigate around access hurdles, with uncertainty remaining around consistent conversion to insurance coverage and sustainability of this approach. While access barriers are a common thread, and also are common across many recently launched biologics in immunology, notable differences are emerging in how Bimzelx is being adopted and perceived across PsA versus axSpA. In PsA, two-thirds of rheumatologists have already prescribed Bimzelx, typically for patients with severe or flaring disease after failing multiple advanced therapies. Many express interest in moving the therapy earlier in the treatment algorithm but, again, remain limited by payer mandates. By contrast, adoption in axSpA is still ramping up, particularly in nr-axSpA, where just a minority of rheumatologists have used the product to date. Though uptake is slower, satisfaction levels remain high among those with prescribing experience, and many physicians expect to expand use as coverage improves. In addition to ramped trial and utilization, promotional efforts from UCB are beginning to resonate. The majority of rheumatologists report contact with Bimzelx sales representatives, who are largely praised for their professionalism and ability to communicate key efficacy and safety differentiators. However, a notable subset of physicians in both PsA and axSpA have yet to be detailed, and limited awareness of support services—such as the Bimzelx Navigate program—suggests more work is needed to fully activate the prescriber base. Those who have engaged with Navigate report a positive experience, citing timely support and ease of use, though these accounts remain limited. As the launches progress, the key question is whether UCB can convert strong clinical perceptions into real-world usage at earlier points in care. While Bimzelx is well-positioned from an efficacy standpoint, its long-term success will hinge on overcoming payer resistance and improving patient access. Spherix Global Insights will continue to track Bimzelx's PsA, AS and nr-AxSpA U.S. launch trajectory through its Launch Dynamix™ service through the first eighteen months of commercial availability. Launch Dynamix™ is an independent service providing monthly benchmarking of newly launched products for the first eighteen months of commercial availability, augmented by a quarterly deep dive into promotional activity, barriers to uptake, and patient types gravitating to the launch brand. About Spherix Global Insights Spherix is a leading independent market intelligence and advisory firm that delivers commercial value to the global life sciences industry, across the brand lifecycle. The seasoned team of Spherix experts provides an unbiased and holistic view of the landscape within rapidly evolving specialty markets, including dermatology, gastroenterology, rheumatology, nephrology, neurology, ophthalmology, and hematology. Spherix clients stay ahead of the curve with the perspective of the extensive Spherix Physician Community. As a trusted advisor and industry thought leader, Spherix's unparalleled market insights and advisory services empower clients to make better decisions and unlock opportunities for growth. To learn more about Spherix Global Insights, visit or connect through LinkedIn. For more details on Spherix's primary market research reports and interactive dashboard offerings, visit or register here: NOTICE: All company, brand or product names in this press release are trademarks of their respective holders. The findings and opinions expressed within are based on Spherix Global Insight's analysis and do not imply a relationship with or endorsement of the companies or brands mentioned in this press release. Lynn Price, Rheumatology Franchise Head Spherix Global Insights 4848794284 [email protected]
Medical News Today
30-05-2025
- General
- Medical News Today
Cosentyx UnoReady and Sensoready pens: What to know about each
Cosentyx UnoReady (secukinumab) and Sensoready (secukinumab) are brand-name injections. They're both prescribed for plaque psoriasis, hidradenitis suppurativa, and certain types of arthritis. Certain factors may determine the injection pen that's right for you. This article explains the main similarities and differences between Cosentyx UnoReady and Sensoready. If you're considering taking one of these drugs, discussing this information with your doctor can help you decide if one of these treatments may be right for you. Cosentyx UnoReady and Sensoready have been approved by the Food and Drug Administration (FDA) to treat the following conditions in adults: Cosentyx UnoReady and Sensoready have been approved by the Food and Drug Administration (FDA) to treat the following conditions in children: The Cosentyx UnoReady pen and Sensoready pen are approved to treat the same conditions, but the pen you're prescribed may depend on your dosage. They also share some features, including: both pens come with a concealed needle, meaning you won't need to purchase needles or attach them to the pen. both pens will sound with a 'click' when the injection starts and when the injection is nearly finished, so you know that you receive the full dose. neither pen requires pressing a button to 'activate' the injection. both pens may be injected in the same body areas: your lower stomach, the front of your thighs, or your upper outer arms (if someone else is giving your injection). But there are differences between them that can determine whether one or the other is a better fit for you. Cosentyx is also available in prefilled syringes. If you'd like to learn about how Cosentyx UnoReady and Sensoready pens compare versus the prefilled syringe, ask your doctor or pharmacist. The Cosentyx UnoReady pen and Sensoready pen are approved to treat the same conditions, but the pen you're prescribed may depend on your dosage. The Cosentyx UnoReady pen delivers a 300-mg dose, while the Cosentyx Sensoready pen delivers a 150-mg dose. Two Sensoready pens may be used to deliver a 300-mg dose. Below are instructions for how to use the Cosentyx UnoReady pen. Your doctor or pharmacist will train you to use the pen to give yourself Cosentyx injections. Let them know if you have questions or concerns about how to use the UnoReady pen. Remove the Cosentyx UnoReady pen from the refrigerator 30 to 45 minutes before your dose. Doing so allows the pen to reach room temperature, making the injection more comfortable. Check the viewing window and ensure that the liquid is clear, and the color is colorless or slightly yellow. Air bubbles may also be visible, which is normal. Wash your hands, then clean the injection site with an alcohol wipe and allow it to dry. You may inject Cosentyx UnoReady doses into your lower stomach, the front of your thighs, or your upper outer arms (if someone else is giving your injection). Do not inject into skin that is bruised, hard, tender, scaly, or red or discolored. You also should not inject into an area of skin affected by psoriasis, or area with scars or stretch marks. Do not shake the UnoReady pen. shake the UnoReady pen. Remove and dispose of the cap. Position the UnoReady pen at a 90-degree angle against the injection site, with the viewing window facing you. Press the pen firmly against the skin and hold. You should hear the first 'click' sound, which indicates the injection has started. Keep holding the pen against your skin. Watch the viewing window on the UnoReady pen; you should see a moving green indicator, which shows the injection progress. You'll hear a second 'click' sound, which indicates the injection is nearly finished. After you hear the second 'click', hold the pen in place for another 5 seconds. Once the green indicator fills the viewing window and has stopped moving, you can remove the UnoReady pen from your skin and dispose of it in a sharps container. When you're first prescribed the Cosentyx Sensoready pen, your doctor or pharmacist will show you how to give yourself injections. Cosentyx Sensoready pen instructions are included below, but reach out to your doctor or pharmacist if you have questions or concerns about how to use Cosentyx Sensoready pens. Remove the Cosentyx Sensoready pen from the refrigerator 15 to 30 minutes before your dose. This allows the pen to reach room temperature, which helps make the injection more comfortable. Look at the Sensoready pen viewing window and ensure the liquid is clear with a colorless or slightly yellow appearance. Air bubbles may also appear, which is normal. If your prescribed dose is 150 mg, you'll give one injection. If your prescribed dose is 300 mg, you'll need to use two Cosentyx Sensoready pens to give two injections. You should choose a different injection site for each injection if your dose requires two injections. Wash your hands, then clean the injection site with an alcohol wipe and allow it to dry. You may inject Cosentyx Sensoready doses into the front of your thighs, your lower stomach, or your upper outer arms (if someone else is giving your injection). Avoid giving an injection into skin that is tender, bruised, red or discolored, hard, or scaly. Do not inject into an area of skin affected by psoriasis, or area with stretch marks or scars. Do not shake the Sensoready pen. shake the Sensoready pen. Remove and throw away the cap. Hold the Sensoready pen at a 90-degree angle against the injection site. Press and hold the Sensoready pen firmly against the skin at the injection site. You should hear the first 'click' sound, which signals the injection has started. Continue holding the Sensoready pen firmly against your skin. Watch the progress of the injection using the 360-degree viewing window on the Sensoready pen. You should see a green moving indicator. When the pen sounds a second 'click', the injection is nearly complete. Continue holding the Sensoready pen against your skin until the green moving indicator fills the viewing window and stops moving. Once the green indicator stops moving, the injection is complete. You may now dispose of the Sensoready pen into a sharps container. If your dose is 300 mg, repeat these steps with a new Sensoready pen at a different injection site. If you're prescribed Cosentyx UnoReady or Sensoready, you may wonder how effective either drug is for treating your condition. Prescribing information: Here's a brief look at how effective Cosentyx UnoReady and Sensoready were found to be in clinical trials. Clinical trials found Cosentyx UnoReady and Sensoeady effective at treating: For details about how these drugs performed in clinical trials, see the prescribing information for Cosentyx UnoReady and Sensoready. Keep in mind that trial results may not apply to your individual health situation. Treatment guidelines: Another way to see whether a drug is considered effective is to look at treatment guidelines. When an organization includes certain drugs in treatment guidelines, this means that research has shown the drug to be safe and effective. Cosentyx UnoReady and Sensoready both contain the same active ingredient (what makes a drug work), secukinumab. Below is information on treatment guidelines that recommend secukinumab as a treatment for approved uses of Cosentyx UnoReady and Sensoready: Cosentyx UnoReady and Sensoready may not be right for you if you have certain medical conditions or other factors that affect your health. The two drugs share some of the same precautions, but they also have different ones. Some of these precautions are mentioned below. If any of the following medical conditions or other health factors are relevant to you, talk with your doctor before using Cosentyx UnoReady or Sensoready. The Cosentyx UnoReady and Sensoready pens are approved to treat the same conditions, but differences between the two can determine which is a better fit for you. A few key differences include: The UnoReady pen cap isn't made with latex, making it a better option if you have a latex allergy. The UnoReady pen can only deliver a 300-mg dose. The Sensoready pen, on the other hand, delivers a 150-mg dose. Two Sensoready pens may be used to give a 300-mg dose. This makes the Sensoready pen more versatile in its dosing options. The UnoReady pen is rectangular in shape, while the Sensoready pen is triangular. You may find one pen more comfortable to hold and use than the other based on your preferences. To learn more about how the Cosentyx UnoReady and Sensoready pens compare, talk with your doctor or pharmacist. They can help decide if either pen is a better option for you. Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses. Psoriasis Psoriatic Arthritis Pharmacy / Pharmacist Drugs Arthritis
