Novartis Cosentyx (Secukinumab, IL-17A Inhibitor Monoclonal Antibody) Receives Positive EU CHMP Opinion in Polymyalgia Rheumatica (PMR); First IL-17 Inhibitor in Class for This Steroid-Refractory Population
Novartis (NYSE: NVS; SIX: NOVN) announced Friday September 18, 2026 that the EMA's CHMP adopted a positive opinion recommending EU marketing authorization for Cosentyx (secukinumab, a fully human IgG1 monoclonal antibody against interleukin-17A) for the treatment of adults with polymyalgia rheumatica (PMR) who have had an inadequate response to steroids or who experience relapse during steroid taper. Upon EC approval, Cosentyx would be the first IL-17A inhibitor licensed in Europe for PMR — a common inflammatory rheumatic disease in adults over 50 with limited advanced treatment options beyond long-term steroids (which carry significant morbidity). The recommendation is anchored on the REPLENISH Phase 3 trial: all primary and secondary endpoints were met across both Cosentyx 300 mg and 150 mg treatment arms, showing doubled sustained remission rates and steroid-sparing benefit versus placebo, with safety consistent with the established Cosentyx profile. European Commission decision is expected by November 2026. Cosentyx generated approximately $6.4 billion in 2025 global sales across its 10+ approved indications.