FDA Action
April 1, 2017 less than 1 minute read
The FDA has approved brodalumab to treat adults with moderate-to-severe plaque psoriasis. The drug, which is administered as a subcutaneous injection, binds the IL-17 receptor. It was approved on the strength of three randomized, placebo-controlled, clinical trials that contained nearly 4,400 adults who are candidates for systemic therapy or phototherapy. More patients treated with brodalumab exhibited skin that was clear or almost clear compared to placebo. Suicidal ideation and behavior occurred at a higher rate during clinical trials and delayed approval of the drug. Eventually, it was approved with a boxed warning and is only available to restricted program under a Risk Evaluation and Mitigation Strategy. Brodalumab is marketed as Siliq.
The FDA has approved brodalumab to treat adults with moderate-to-severe plaque psoriasis.
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