Novartis Receives Positive CHMP Opinion for Cosentyx in PMR

Basel, September 18, 2026, Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization for Cosentyx® (secukinumab) in polymyalgia rheumatica (PMR). If approved, Cosentyx will be the first interleukin-17A (IL-17A) inhibitor licensed in Europe for adults with PMR, providing a new treatment option after steroids.

The recommendation is based on data showing that Cosentyx doubled sustained remission rates and delivered steroid-sparing effects compared to placebo. Safety was consistent with the established profile of Cosentyx. Despite being a common inflammatory rheumatic disease in people over 50, PMR has limited advanced treatment options, and extended use of steroids is associated with poor outcomes.

The positive CHMP opinion is supported by results from the pivotal REPLENISH Phase III trial, which evaluated the efficacy and safety of Cosentyx in patients with PMR. The trial, conducted across 27 countries, met all primary and secondary endpoints across both Cosentyx 300mg and 150mg treatment arms, including complete sustained remission and time until patients needed additional treatment through week 52. No new safety signals were identified in PMR patients receiving Cosentyx.

The REPLENISH trial (NCT05767034) is a global, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Patients were randomized into three treatment arms: Cosentyx 300mg, Cosentyx 150mg, or placebo, all in combination with a 24-week steroid taper regimen. The primary endpoint was to assess whether Cosentyx 300mg subcutaneously (s.c.) plus a 24-week steroid taper is superior to placebo plus a 24-week steroid taper in achieving sustained remission at week 52. Key secondary endpoints included the proportion of patients achieving complete sustained remission at week 52, the adjusted annual cumulative steroid dose, and the time to first use of escape or rescue treatment through week 52.

Polymyalgia rheumatica is a common inflammatory rheumatic disease in adults aged 50 years and older, typically characterized by acute pain and stiffness in the shoulders, neck, and hips. Relapses are frequent, affecting up to 40% of patients in the first year. Long-term steroid use is the current standard of care and carries significant risks, including osteoporosis and diabetes. Beyond physical complications, PMR substantially impairs quality of life through pain, fatigue, restricted mobility, and fear of relapse.

The positive CHMP opinion is a significant advancement for patients and clinicians, providing an effective treatment option while reducing reliance on steroids, which can present challenges with long-term use.

Following the CHMP recommendation for approval, the European Commission (EC) is expected to issue a final decision within approximately two months. Cosentyx is a fully human biologic that directly inhibits interleukin-17A, an important cytokine involved in the inflammation underlying multiple immune-mediated inflammatory diseases. It is approved for use in adults with psoriatic arthritis, moderate to severe plaque psoriasis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and hidradenitis suppurativa. Cosentyx is also approved for use in pediatric patients, including those with psoriasis and juvenile idiopathic arthritis subtypes such as juvenile psoriatic arthritis and enthesitis-related arthritis.