Post-Marketing Registry, Suicidality Warning Could Be Paradox For Siliq
Labeling for Valeant’s pending plaque psoriasis treatment might warn about the potential for suicide; if that's effective, though, will the company be able to enroll meaningful numbers of patients in its registry that aims for a definitive answer?
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Measures are aimed at mitigating risk of suicidal ideation and behavior with the psoriasis drug, but company will not have to conduct a postmarketing registry to evaluate this risk.
While an FDA advisory committee unanimously supported approval of the plaque psoriasis drug brodalumab, several recommended a black box warning on suicide risk that could limit sales of the drug.
Agency's advisors were divided on whether Valeant's proposal for voluntary registry would suffice or whether mandatory program under REMS was needed to better assess risk of suicide and suicidal behavior with psoriasis drug.