Valeant wins first round in $445M gamble on brodalumab approval
Valeant made an unusual appearance in front of an FDA expert panel on Tuesday, and came out with a clear endorsement for an FDA approval of their psoriasis drug brodalumab.
The panel voted 18 to 0 in favor of approving brodalumab, despite the agency’s internal review, which linked the drug to 6 suicides and suicidal ideation as well as cardio risks. Four of the panelists recommended an approval with nothing more than a clear label warning on the risks involved, 14 voted yes on an approval with a risk management plan in place.
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