The FDA has come through with an approval for Valeant’s psoriasis drug brodalumab. But they’ve hobbled it with a black box safety warning on suicidal ideation and a risk mitigation marketing program that will likely hobble its revenue in an intensely competitive market.
An FDA panel already flagged through the drug – to be sold as Siliq – with many of the experts clearly more interested in obtaining another arrow for their quiver rather than the potential safety issues, which they felt were manageable.
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