Brodalumab regulatory update

FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee voted unanimously to recommend approval of brodalumab from Valeant to treat moderate to severe plaque psoriasis. The human IgG2 mAb against IL-17 receptor (IL17R; IL17RA) has a Nov. 16 PDUFA date. Four committee members voted that risks of suicidal ideation and behavior (SIB) could be managed with labeling alone, while the other 14 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 risk of SIB based on 6 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).

Several panelists agreed with Valeant’s proposed risk management plan, which included addition of SIB to the warnings and precautions section of brodalumab’s label, a quarterly review of postmarketing safety data by independent experts, a medication guide and communication plan and voluntary enrollment of patients in a registry. Those who criticized the proposed strategy were primarily concerned with whether a voluntary registry study would clarify the candidate’s SIB risk as well as whether a mandatory registry study or a randomized postmarketing study would. ...