FDA advisors voted to approve Valeant's experimental psoriasis drug, brodalumab, provided the drugmaker takes extra steps to mitigate possible suicide risk associated with the drug.
The panel recommended that the agency clear the drug for sale with a risk-management plan and a label that warns it may be linked to a higher risk of suicide after six suicides occurred in clinical trials of the treatment. Panel members agreed, however, that link between the suicides and the drug was not clear.
Valeant paid $100 million to acquire the commercial rights to brodalumab from AstraZeneca in September. In May 2015, Amgen terminated an agreement with AstraZeneca on the experimental drug after patients reported suicidal thoughts during clinical testing.
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