EMA panel backs Novartis Cosentyx for rheumatic condition in EU

Novartis (NYSE: NVS) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization for Cosentyx (secukinumab) in polymyalgia rheumatica (PMR).

The opinion supports the use of Cosentyx for the treatment of PMR in adults who have had an inadequate response to steroids or who experience relapse during steroid taper.

The positive CHMP opinion is supported by results from the pivotal Replenish Phase III trial.

Following the CHMP recommendation, the European Commission is expected to issue a final decision within approximately two months, according to the company's statement.

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