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FDA Panel Backs Psoriasis Drug Brodalumab With Risk-Mitigation Program
The FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee has voted unanimously (18 to 0) for the approval of brodalumab injection 210 mg (Valeant Pharmaceuticals) for adults with moderate-to-severe plaque psoriasis. Of those 18, 14 voted that the drug should be prescribed only in conjunction with a strong risk evaluation and mitigation strategy (REMS) that goes beyond simply including the information in the label. Such programs may include medication guides and communication plans for health care providers.
Panelists said that there was a need for new psoriasis drugs and that they would like to have brodalumab available as an option, according to a Reuters report. They offered various suggestions about how to mitigate the suicide risk associated with the medication, including a boxed warning and a patient registry to collect patient data and to more clearly assess the risk.
Some thought the registry should be mandatory, and others thought it should be voluntary. Some thought any registry would create unnecessary barriers to accessing the drug and may not reflect a true estimate of the suicide risk.
The committee’s recommendations will be considered by the FDA in its review of the biologics license application for brodalumab. The agency has assigned a Prescription Drug User Fee Act (PDUFA) action date of November 16, 2016.
Brodalumab is a human monoclonal antibody that binds to the interleukin-17 (IL-17) receptor and inhibits inflammatory signalling by blocking the binding of several types of IL-17 to the receptor. By stopping IL-17 from activating the receptor, brodalumab prevents the body from receiving signals that may lead to inflammation. The IL-17 pathway plays a central role in inducing and promoting inflammatory disease processes.
Sources: Valeant Pharmaceuticals; July 19, 2016; and Reuters; July 19, 2016.