Novartis AGCHMP positive opinion recommends EU marketing authorization for Cosentyx in polymyalgia rheumatica, advancing toward European Commission approval.

Novartis announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending marketing authorization for Cosentyx, also known as secukinumab, in polymyalgia rheumatica. The opinion supports use in adults who have had an inadequate response to steroids or who relapse during steroid taper, and if approved, Cosentyx would be the first interleukin-17A inhibitor licensed in Europe for the disease. The recommendation rests on the pivotal REPLENISH Phase III trial, in which all primary and secondary endpoints were met across both the Cosentyx 300mg and 150mg arms, including complete sustained remission and time until patients needed additional treatment through week 52, with no new safety signals identified. Those data were published in the New England Journal of Medicine and presented at the 2026 European Alliance of Associations for Rheumatology Congress on June 3, 2026. The European Commission is expected to issue a final decision within approximately two months.
Novartis AGCHMP positive opinion recommends EU marketing authorization for Cosentyx in polymyalgia rheumatica, advancing toward European Commission approval.