Novartis receives European Commission approval for Cosentyx® in polymyalgia rheumatica (PMR)

manilatimes.net · 2026-10-21

Cosentyx® (secukinumab) becomes first and only IL-17A inhibitor approved in Europe for adults with PMR,1 a common inflammatory rheumatic disease with limited advanced treatment options2-6Approval based on Phase III REPLENISH trial showing Cosentyx doubled sustained remission rates vs placebo at Week 52; safety results consistent with established Cosentyx profile7Additional regulatory reviews of Cosentyx in PMR ongoing globally, including in US and JapanBasel, October 21, 2026 - Novartis announced today that the European Commission (EC) has approved Cosentyx® (secukinumab) for the treatment of adults with polymyalgia rheumatica (PMR) who have had an inadequate response to glucocorticoids or who experience relapse during glucocorticoid taper. With this approval, Cosentyx becomes the first and only interleukin-17A (IL-17A) inhibitor approved in Europe for adults with PMR.1

TickrTrends take: Novartis's European Commission approval for Cosentyx in polymyalgia rheumatica represents a label expansion for an existing drug into a new indication, which could contribute incremental revenue to the company's immunology portfolio. For investors focused on REGN's valuation, competitive dynamics in the immunology and rheumatology space warrant monitoring, as approvals by competitors may influence market share and pricing pressures in segments where both companies operate. TickrTrends currently assesses REGN as fairly valued within the Healthcare sector, suggesting the market has already factored in known competitive and pipeline considerations.

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