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FDA approved Valeant’s brodalumab with a boxed warning for suicidal ideation.
On Feb. 15, 2017, FDA approved Valeant’s Siliq (brodalumab) for the treatment of moderate-to-severe plaque psoriasis. The monoclonal antibody (mAb) works by binding to the IL-17 receptor and is meant for patients who are candidates for systemic therapy or phototherapy, and have failed to respond or stopped responding to other systemic therapies.
Brodalumab does have some notable adverse events, FDA said in a statement. During clinical trials, there were instances of patients demonstrating suicidal ideation. FDA noted, however, that a casual association between brodalumab and an increased risk of suicidal behavior or ideation has not been established. Because of this risk, the drug will come with a boxed warning and will only be available under a Risk Evaluation and Mitigation Strategy (REMS) program.
In 2015, Amgen dropped out of co-developing the mAb with AstraZeneca when it became clear patients were demonstrating thoughts of suicide. In September 2015, Valeant took over the commercialization and development of the mAb.