CHMP backs potential new European indication for Cosentyx
Novartis won a positive CHMP opinion backing Cosentyx for polymyalgia rheumatica, positioning it for a potential new European indication.
Phase III REPLENISH results were presented at the 2026 EULAR congress, then published in the New England Journal of Medicine.
The study showed Cosentyx improved sustained remission and reduced steroid reliance versus placebo, with no new safety concerns flagged.
The recommended use targets adults who relapse during steroid taper or respond inadequately to steroids, expanding Cosentyx beyond its core autoimmune franchises.
A European Commission decision is expected within about two months, setting the timeline for a potential label expansion and launch planning.
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