Novartis announced 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).⁸ The opinion supports Cosentyx use for treatment of PMR in adults who have had an inadequate response to steroids or who experience relapse during steroid taper.⁸ If approved, Cosentyx would be the first interleukin-17A (IL-17A) inhibitor approved in Europe for people living with PMR, a disease with very limited advanced treatment options.

“The introduction of Cosentyx to the PMR space represents a major advancement for patients and clinicians, providing an effective treatment option while also reducing reliance on steroids – which can present challenges with long-term use,” said Prof Christian Dejaco, Director, Dept of Rheumatology, South Tyrol Health Trust, Bruneck, Italy. “I am encouraged by this positive CHMP opinion for a treatment which could both reduce flares and lower patients’ steroid exposure.”

The positive CHMP opinion is supported by results from the pivotal REPLENISH Phase III trial in which all primary and secondary endpoints were met across both Cosentyx 300mg and 150mg treatment arms, including complete sustained remission and time until patients needed additional treatment through week 52.² No new safety signals were identified in PMR patients receiving Cosentyx. The data were published in the New England Journal of Medicine and simultaneously presented at the 2026 European Alliance of Associations for Rheumatology (EULAR) Congress on June 3, 2026.²˒⁹

“People living with PMR need treatments that provide lasting remission, prevent relapses and are well-tolerated, in order to achieve the best possible long-term outcomes,” said Patrick Horber, M.D., President, International, Novartis. “Cosentyx is the first and only anti-IL-17A shown to provide sustained remission in patients with PMR, and its approval would represent an important step in transforming care for those living with this disease. Today’s positive opinion builds on the well-established impact of Cosentyx in autoimmune disease and could help establish a new standard of care for PMR in Europe.”

Following the CHMP recommendation for approval, the European Commission (EC) is expected to issue a final decision within approximately two months.