Basel, Switzerland, September 18, 2026
Novartis has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization for Cosentyx® (secukinumab) for adults with polymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or experienced relapse during steroid tapering. If the European Commission grants final approval, Cosentyx would become the first IL-17A inhibitor approved in Europe for PMR, potentially providing another treatment approach for patients whose disease remains difficult to control with steroid therapy. The CHMP recommendation is based on results from the pivotal Phase III REPLENISH trial, which met all primary and secondary endpoints across the evaluated Cosentyx treatment groups.
Novartis Receives Positive CHMP Opinion for Cosentyx
The positive CHMP opinion represents an important regulatory milestone for Novartis as the company seeks to expand the use of Cosentyx into polymyalgia rheumatica. PMR is an inflammatory rheumatic disease that primarily affects adults aged 50 years and older and is commonly associated with pain and stiffness in the shoulders, neck and hips. Although corticosteroids remain the established treatment approach, patients can experience relapses and may require prolonged steroid exposure. Novartis said the proposed Cosentyx indication is intended for adults who have not responded adequately to steroids or who relapse while reducing steroid treatment.
The CHMP recommendation follows evidence from the REPLENISH Phase III study, a global, multicenter, randomized, double-blind, placebo-controlled clinical trial conducted across 27 countries. The study evaluated Cosentyx at 300 mg and 150 mg doses against placebo, with all treatment groups receiving a 24-week steroid taper. The primary endpoint assessed whether Cosentyx 300 mg combined with the steroid taper was superior to placebo plus the same taper in achieving sustained remission at Week 52. Key secondary measures included complete sustained remission, cumulative steroid exposure and time to additional rescue or escape treatment.
Phase III REPLENISH Data Support Regulatory Recommendation
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According to Novartis, the REPLENISH trial met all primary and secondary endpoints across both Cosentyx dose groups. The company reported that Cosentyx demonstrated sustained remission and steroid-sparing effects compared with placebo, while no new safety signals were identified among PMR patients receiving the medicine. The findings were published in the New England Journal of Medicine and presented at the 2026 European Alliance of Associations for Rheumatology (EULAR) Congress in June.
The clinical findings are relevant because relapses are common in PMR, and extended corticosteroid treatment can be associated with complications including osteoporosis and diabetes. Novartis said the Cosentyx data indicate the potential for a treatment strategy that combines disease control with reduced steroid exposure. However, the CHMP opinion is a recommendation rather than final European marketing authorization. The European Commission is expected to make the final decision following the CHMP recommendation.
Cosentyx Expands Its Immunology Development Program
Cosentyx (secukinumab) is a fully human biologic that selectively inhibits interleukin-17A (IL-17A), a cytokine involved in inflammatory processes associated with several immune-mediated diseases. The medicine is already approved for multiple conditions, including psoriatic arthritis, moderate-to-severe plaque psoriasis, ankylosing spondylitis, non-radiographic axial spondyloarthritis and hidradenitis suppurativa. A PMR approval would therefore expand the established clinical use of secukinumab into another inflammatory rheumatic disease. For Novartis, the positive CHMP opinion adds another regulatory development to the company’s broader immunology portfolio. The potential PMR indication also highlights continued research into targeted biologic therapies for inflammatory diseases in which patients may experience persistent symptoms, recurrent disease activity or challenges associated with long-term corticosteroid use.
If the European Commission confirms the recommendation, Cosentyx could become an additional treatment option for eligible adults with PMR in Europe. Until that final regulatory decision is made, the proposed indication remains subject to the European authorization process. The CHMP recommendation nevertheless represents a significant development in the clinical and regulatory program for secukinumab in polymyalgia rheumatica.
Source: Novartis press release
