ARTICLE | Company News

CHMP backs psoriasis treatments from Novartis, Celgene

November 22, 2014 2:24 AM UTC

EMA's CHMP recommended marketing authorization for Cosentyx secukinumab from Novartis AG (NYSE:NVS; SIX:NOVN) as a first-line treatment for adults with moderate to severe plaque psoriasis and Otezla apremilast from Celgene Corp. (NASDAQ:CELG) to treat active psoriatic arthritis and moderate to severe chronic plaque psoriasis in adults. CHMP said marketing authorization for both products would include a pharmacovigilance plan.

Last month, FDA's Dermatologic and Ophthalmic Drugs Advisory Committee voted unanimously to recommend approval of Cosentyx for moderate to severe plaque psoriasis. Novartis submitted a BLA for the human IgG1 mAb targeting IL-17 in October 2013; the PDUFA date is not disclosed. The compound is the first therapy targeting IL-17 recommended for approval in Europe for this indication. ...