Novartis wins positive CHMP backing for Cosentyx in PMR

Novartis announced on 18 September 2026 that the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended marketing authorization for Cosentyx (secukinumab) to treat polymyalgia rheumatica. The recommendation covers adults with the rheumatic condition who had an inadequate response to steroids or suffered a relapse during steroid reduction. If approved, Cosentyx will become the first interleukin-17A inhibitor licensed in Europe for this disease.

The recommendation relies on results from the global Phase III REPLENISH trial across 27 countries. The study evaluated patients randomized to Cosentyx 300 mg, Cosentyx 150 mg, or placebo alongside a 24-week steroid taper. All primary and secondary endpoints were met across both dose arms through week 52, including complete sustained remission and time until additional treatment was required. Trial data showed Cosentyx doubled sustained remission rates compared with placebo, without identifying new safety signals.

Patrick Horber, President, International at Novartis, stated that the drug is the first and only anti-IL-17A therapy shown to provide sustained remission in polymyalgia rheumatica patients. The European Commission is scheduled to issue its final regulatory decision within approximately two months.