Novartis’s Cosentyx® receives positive CHMP opinion for treating polymyalgia rheumatica

If approved, Cosentyx would become the first IL-17A inhibitor licensed in Europe for adults with polymyalgia rheumatica, offering a new treatment option beyond steroids. The recommendation is based on data showing Cosentyx doubled sustained remission rates and produced steroid-sparing effects compared with placebo, with a safety profile consistent with its established track record. Despite being a common inflammatory rheumatic condition among people over 50, advanced treatment options for polymyalgia rheumatica remain limited, and extended steroid use is linked to poor outcomes.

Novartis announced that the Committee for Medicinal Products for Human Use at the European Medicines Agency has adopted a positive opinion recommending marketing authorization for Cosentyx in polymyalgia rheumatica. The opinion supports using Cosentyx to treat the condition in adults who have not responded adequately to steroids or who relapse while tapering off them. If approved, Cosentyx would become the first interleukin-17A inhibitor cleared in Europe for people living with polymyalgia rheumatica, a disease that currently has very few advanced treatment options.

Prof. Christian Dejaco, director of the Department of Rheumatology at the South Tyrol Health Trust in Bruneck, Italy, said bringing Cosentyx into the polymyalgia rheumatica space represents a major step forward for both patients and clinicians, offering an effective treatment while also reducing dependence on steroids, which can pose challenges with long-term use. He said he was encouraged by the positive CHMP opinion for a treatment capable of both reducing flares and lowering patients’ overall steroid exposure.

The positive opinion is backed by results from the pivotal Phase III REPLENISH trial, in which all primary and secondary endpoints were met across both the 300 mg and 150 mg Cosentyx treatment arms, including complete sustained remission and the time until patients required additional treatment through week 52. No new safety signals emerged among patients with polymyalgia rheumatica treated with Cosentyx. The findings were published in the New England Journal of Medicine and presented simultaneously at the 2026 European Alliance of Associations for Rheumatology Congress on June 3, 2026.

Patrick Horber, M.D., president of International at Novartis, said people living with polymyalgia rheumatica need treatments that offer lasting remission, prevent relapses, and are well tolerated in order to achieve the best possible long-term outcomes. He said Cosentyx is the first and only anti-IL-17A therapy shown to produce sustained remission in patients with the condition, and that its approval would mark an important step toward transforming care for those affected. He added that this positive opinion builds on Cosentyx’s well-established track record in autoimmune disease and could help set a new standard of care for polymyalgia rheumatica in Europe.

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CHMP opinion, Cosentyx, Novartis, Novartis's Cosentyx, polymyalgia rheumatica