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FDA panel backs Valeant's brodalumab with risk plan

July 19, 2016 7:00 AM UTC

On Tuesday, FDA's Dermatologic and Ophthalmic Drugs Advisory Committee voted unanimously to recommend approval of brodalumab ( KHK4827) from Valeant Pharmaceuticals International Inc. (TSX:VRX; NYSE:VRX) to treat moderate to severe plaque psoriasis. Four committee members voted that risks of suicidal ideation and behavior (SIB) could be managed with labeling alone, while the other fourteen voted that additional risk management options would be needed. Several members suggested a black box warning.

Neither FDA nor committee members questioned brodalumab's efficacy. The committee could neither confirm nor rule out an increased SIB risk based on six completed suicides among 6,781 patients who received brodalumab for any indication. Members generally did not think brodalumab increased risk of major adverse cardiovascular events (MACE). ...