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Post-Marketing Registry, Suicidality Warning Could Be Paradox For Siliq

Executive Summary

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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US FDA Approval Of Valeant’s Siliq Comes With REMS, Boxed Warning

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.

Suicide Warnings For Valeant’s Siliq Could Hinder Access To Psoriasis Treatment

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.

Valeant's Siliq Clears FDA Panel But Faces Prospect Of Post-Marketing Registry

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.

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