Novartis obtains European Commission clearance for Cosentyx in polymyalgia rheumatica
Novartis received approval from the European Commission to market its drug Cosentyx (secukinumab) for adults with polymyalgia rheumatica who do not respond adequately to glucocorticoids. The decision follows results from the Phase III REPLENISH study, which showed a two‑fold increase in sustained remission versus placebo at week 52. The clearance makes Cosentyx the inaugural IL‑17A inhibitor authorized in Europe for this condition. Regulatory reviews for the same indication are continuing in the United States and Japan.
Why it matters
The approval adds a new therapeutic indication for Cosentyx, potentially expanding Novartis' revenue base in Europe, according to the company’s press release. Being the first IL‑17A blocker approved for polymyalgia rheumatica may give Novartis a competitive advantage in pricing and market uptake.
Key facts
- 1The European Commission granted approval for Cosentyx to treat adult polymyalgia rheumatica patients who have an inadequate response to glucocorticoids or relapse during tapering. tradingview.com
- 2Approval was based on the Phase III REPLENISH trial, which demonstrated that Cosintyex doubled sustained remission rates compared with placebo at week 52. tradingview.com
- 3Cosentyx becomes the first IL‑17A inhibitor approved in Europe for polymyalgia rheumatica. tradingview.com
- 4Regulatory reviews for the same indication are ongoing in the United States and Japan. tradingview.com
Summary written by AlphAI AI Desk from 6 of 6 sources. Not investment advice. Figures are as stated by the linked sources.