Secukinumab regulatory update

FDA's Dermatologic and Ophthalmic Drugs Advisory Committee voted 7-0 to recommend approval of Cosentyx secukinumab from Novartis to treat moderate to severe plaque psoriasis. 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. The primary safety concern in trials was an increased risk of infection, which panelists agreed was clinically manageable. ...