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Novartis has received the EC’s approval for Cosentyx (secukinumab) to treat adults with polymyalgia rheumatica (PMR) who have had an inadequate response to glucocorticoids or who experience relapse during glucocorticoid taper, making it the 1st & only IL-17A inhibitor approved in Europe for adults with PMR
Approval was based on the global P-III (REPLENISH) trial across 27 countries evaluating Cosentyx (300mg or 150mg) vs PBO, each with a 24wk steroid taper, in which Cosentyx doubled sustained remission rates vs PBO at Wk 52, with safety consistent with its established profile
Recommended dose is 150mg SC at Wks 0, 1, 2, 3 & 4, followed by monthly maintenance dosing with a tapering course of glucocorticoids, after which Cosentyx can be continued as monotherapy (maintenance dose may be increased to 300mg); regulatory reviews in PMR are ongoing globally, incl. in the US & Japan
Ref: Novartis | Image: Novartis | Press Release
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The post Novartis Receives the EC’s Approval for Cosentyx (Secukinumab) to Treat Polymyalgia Rheumatica (PMR) appeared first on PharmaShots.
Novartis Receives the EC’s Approval for Cosentyx (Secukinumab) to Treat Polymyalgia Rheumatica (PMR) | PharmaVoice