Basel, Switzerland, October 21, 2026
Novartis has received European Commission approval for Cosentyx® (secukinumab) to treat adults with polymyalgia rheumatica (PMR) who have an inadequate response to glucocorticoids or experience a relapse while reducing their steroid treatment. The approval introduces a new targeted treatment option for people living with this inflammatory rheumatic disease, which primarily affects adults aged 50 and older. Cosentyx is the first and only interleukin-17A (IL-17A) inhibitor approved in Europe for PMR, according to the company. The regulatory decision is supported by results from the Phase III REPLENISH clinical trial, which demonstrated improved sustained remission compared with placebo. The approval also expands the medicine’s role in immune-mediated inflammatory diseases and addresses an important treatment challenge for patients who require prolonged steroid therapy.
Cosentyx Offers a New Treatment Option for PMR
Polymyalgia rheumatica is an inflammatory condition characterized by pain and stiffness, particularly in the shoulders, neck and hips. Symptoms can interfere with mobility, sleep and everyday activities, significantly affecting quality of life. Although glucocorticoids are commonly used to manage PMR, some patients experience repeated relapses or have difficulty reducing their medication without symptoms returning. Long-term steroid treatment can also increase the risk of complications, including osteoporosis, diabetes and other adverse health outcomes. These challenges highlight the need for additional treatments that can help control inflammation while reducing dependence on prolonged glucocorticoid use. Cosentyx contains secukinumab, a fully human monoclonal antibody that selectively inhibits interleukin-17A, a cytokine involved in inflammatory processes. By blocking IL-17A activity, the medicine is designed to reduce inflammation associated with immune-mediated diseases. The European Commission’s approval specifically covers adults with PMR who have not responded adequately to glucocorticoids or who experience relapse during glucocorticoid tapering. The authorization provides clinicians with an additional targeted option for eligible patients whose disease remains difficult to manage with conventional treatment.
Phase III REPLENISH Trial Demonstrates Sustained Remission
The approval was supported by findings from the Phase III REPLENISH trial, a randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of Cosentyx in adults with PMR. The trial compared two secukinumab dose groups, 150 mg and 300 mg, with placebo, alongside a 24-week glucocorticoid tapering regimen. The study met its primary endpoint, demonstrating that Cosentyx 300 mg combined with glucocorticoid tapering was superior to placebo combined with the same tapering regimen in achieving sustained remission at Week 52. The company also reported that both Cosentyx dose groups met the trial’s secondary endpoints, including measures of complete sustained remission and time until additional rescue treatment was required. Sustained remission is an important treatment goal in PMR, as recurring symptoms can lead to repeated steroid exposure and prolonged disease management challenges. The study also demonstrated steroid-sparing effects, supporting further evaluation of secukinumab as a treatment option for patients who struggle to taper glucocorticoids. Safety findings were consistent with the established safety profile of Cosentyx, and the company reported no new safety signals in the PMR clinical program. As with all prescription medicines, treatment decisions should consider the patient’s medical history, potential risks and the approved prescribing information.
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European Approval Expands Novartis Immunology Portfolio
For Novartis, the European Commission decision represents an important milestone in expanding Cosentyx into another inflammatory disease indication. The medicine is already approved for several immune-mediated conditions, including plaque psoriasis, psoriatic arthritis and axial spondyloarthritis. The PMR approval strengthens the company’s immunology portfolio and introduces a targeted therapeutic approach for patients who face limitations with conventional steroid treatment. Additional regulatory reviews for Cosentyx in PMR are ongoing in other markets, including the United States and Japan, according to Novartis. The European authorization does not automatically establish approval in other countries, where regulatory decisions are made independently. Access and reimbursement will also depend on local healthcare systems and national requirements. The approval marks progress in the treatment of polymyalgia rheumatica, particularly for adults who experience inadequate disease control or relapse during steroid reduction. Further real-world experience will help clarify how secukinumab performs in routine clinical practice and how it can be incorporated into long-term disease management. For patients and healthcare professionals, Cosentyx adds another treatment option aimed at achieving sustained disease control while addressing the challenges associated with prolonged glucocorticoid use.
Source: Novartis press release
