Novartis Cosentyx wins positive EU CHMP opinion for polymyalgia rheumatica after Phase III trial success

Bitget2026/09/18 14:52

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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.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Novartis AG published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202609181051OMX_____CNEWS_EN_GNW1001263485_en) on September 18, 2026, and is solely responsible for the information contained therein.

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