Novartis receives positive CHMP opinion for Cosentyx® in polymyalgia rheumatica (PMR)
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization for Novartis's Cosentyx (secukinumab) for treating polymyalgia rheumatica (PMR) in adults. If approved, it would be the first IL-17A inhibitor licensed in Europe for PMR, offering an alternative to long-term steroid therapy. The recommendation is based on Phase III REPLENISH trial data showing Cosentyx doubled sustained remission rates and provided steroid-sparing effects compared to placebo, with a safety profile consistent with its established use in other autoimmune diseases.