BioCentury
ARTICLE | Clinical News

Cosentyx secukinumab regulatory update

January 26, 2015 8:00 AM UTC

The European Commission and FDA approved Cosentyx secukinumab from Novartis to treat moderate to severe plaque psoriasis. Novartis plans to launch the human IgG1 mAb targeting IL-17A in the U.S. and EU “in the coming months,” but declined to disclose the drug’s price. Cosentyx is indicated in the U.S. in adult patients who are candidates for systemic therapy or phototherapy and in the EU as a first-line treatment in adults who are candidates for systemic therapy.

FDA said the drug is being approved with a medication guide to inform patients that, because the drug affects the immune system, they may have a greater risk of infection. Novartis has committed to running a postmarket registry to track the safety outcomes of at least 4,000 patients over eight years. ...