Novartis wins EU approval for Cosentyx in rheumatic disease

Novartis (NYSE: NVS) announced that the European Commission 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.

According to the company, Cosentyx is the first interleukin-17A (IL-17A) inhibitor approved in Europe for adults with PMR, a common inflammatory rheumatic disease in adults over 50 characterized by pain and stiffness in the shoulders, neck, and hips.

The approval is supported by data from the Phase III REPLENISH trial. The recommended dose for adults with PMR is 150 mg by subcutaneous injection at weeks 0, 1, 2, 3, and 4, followed by monthly maintenance dosing in combination with a tapering course of glucocorticoids. Cosentyx can then be continued as monotherapy, with the option to increase the maintenance dose to 300 mg based on clinical response.

"The approval of secukinumab marks an important advancement for people living with PMR and has the potential to transform how we manage this disease beyond prolonged steroid use alone," said Prof. Christian Dejaco, Director of the Department of Rheumatology at South Tyrol Health Trust in Bruneck, Italy.

PMR has historically been managed with prolonged steroid use, which is associated with high relapse rates and adverse outcomes. The company stated that advanced treatment options for the condition have remained limited.

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