The European Commission has approved Novartis’ Cosentyx for adults with polymyalgia rheumatica who respond inadequately to glucocorticoids or relapse while reducing their steroid dose.
The decision makes Cosentyx, also known as secukinumab, the first interleukin-17A inhibitor approved in Europe for the condition, according to Novartis. Regulatory reviews for this use remain underway in the United States, Japan and other markets.
Polymyalgia rheumatica is an inflammatory disease primarily affecting adults older than 50. It causes pain and stiffness in the shoulders, neck and hips and is particularly prevalent among people of Northern European descent.
Treatment typically involves prolonged steroid use. Novartis said relapses and adverse effects associated with long-term steroids remain challenges, while advanced treatment options are limited.
The approval was supported by the Phase 3 REPLENISH trial, which showed Cosentyx doubled sustained remission rates compared with placebo at Week 52. The announcement did not provide the absolute remission rates or detailed statistical results.
Safety findings were consistent with Cosentyx’s established profile, the company said, without providing specific adverse-event figures.
The recommended starting regimen is a 150-milligram injection under the skin at Weeks 0, 1, 2, 3 and 4, followed by monthly maintenance treatment.
Cosentyx is initially given alongside a tapering course of glucocorticoids and may continue alone after steroids are stopped. Depending on clinical response, the maintenance dose can increase to 300 milligrams.
Christian Dejaco, a rheumatology specialist at South Tyrol Health Trust in Italy, said the treatment could help patients maintain disease control while reducing steroid use.
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