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FDA panel backs Novartis' secukinumab for psoriasis

October 21, 2014 2:38 AM UTC

FDA's Dermatologic and Ophthalmic Drugs Advisory Committee voted 7-0 to recommend approval of Cosentyx secukinumab from Novartis AG (NYSE:NVS; SIX:NOVN) to treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. The PDUFA date is not disclosed; Novartis submitted the BLA in October 2013.

Panelists agreed secukinumab showed efficacy and that the increased efficacy of a 300 mg dose vs. a 150 mg dose outweighed safety concerns, regardless of patient weight. Members said a 150 mg dose could be appropriate in special cases. ...