Novartis wins EC approval for Cosentyx in polymyalgia rheumatica

Secukinumab becomes the first IL-17A inhibitor approved in Europe for PMR after Phase III data showed doubled sustained remission rates.

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A brightly lit medical room features an IV pole with a medical pump, a light grey recliner, a green plant, light blue and wood cabinets with a sink, and a window with sheer white curtains.

Novartis has secured European Commission approval for Cosentyx (secukinumab) in polymyalgia rheumatica, making it the first interleukin-17A inhibitor cleared for the indication in Europe. The decision covers adults with PMR who have had an inadequate response to glucocorticoids or who relapse during steroid tapering.

PMR is an inflammatory rheumatic condition affecting adults over 50, causing acute pain and stiffness in the shoulders, neck and hips. Relapses occur in up to 40% of patients within the first year of diagnosis, and long-term steroid use, the current standard of care, carries well-documented risks including osteoporosis and diabetes.

Trial data

The approval rests on data from REPLENISH, a global Phase III, randomised, double-blind, placebo-controlled study conducted across 27 countries. Patients were assigned to secukinumab 300 mg, secukinumab 150 mg, or placebo, each combined with a 24-week steroid taper. The primary endpoint assessed whether secukinumab 300 mg was superior to placebo in achieving sustained remission at Week 52. Novartis reported that Cosentyx doubled sustained remission rates versus placebo at that timepoint; full results were published in the New England Journal of Medicine in 2026 and presented at EULAR in June.

The approved dosing regimen for PMR is 150 mg by subcutaneous injection at Weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing alongside a steroid taper, with an option to escalate to 300 mg based on clinical response.

Prof. Christian Dejaco, Director of the Department of Rheumatology at South Tyrol Health Trust in Italy, said the drug's "ability to help patients achieve sustained disease control while tapering steroids, together with its established safety profile, may help address a longstanding challenge in PMR care."

Market context and competitive landscape

Until now, the only biologic approved in Europe specifically for PMR was sarilumab (Kevzara, Sanofi/Regeneron), an IL-6 receptor antagonist that received its European indication in 2022. Secukinumab's approval introduces a second mechanistic class into the PMR treatment algorithm and gives physicians a choice between IL-6 and IL-17A inhibition depending on patient profile and tolerability. That distinction could prove commercially significant as prescribers build experience with both pathways.

Cosentyx is already one of the highest-selling biologics in immunology globally, with established approvals across psoriasis, psoriatic arthritis, ankylosing spondylitis and hidradenitis suppurativa. Adding PMR extends the drug's addressable patient base without requiring a new manufacturing platform, improving the return on Novartis's existing bioprocessing infrastructure.

Regulatory reviews of secukinumab in PMR remain ongoing in the United States and Japan. A US approval, if granted, would represent a more substantial commercial opportunity given market size, and investors will watch for an FDA decision date as the next key milestone. The IL-17A class has a well-characterised safety profile built across large patient populations in other indications, which should facilitate label negotiations in those markets.

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