Valeant's Brodalumab Faces Conflicting FDA Views On Suicide Risk
Advisory committee will hear agency reviewers' different conclusions on plaque psoriasis drug's approvability due to potential psychiatric effects and whether a REMS can help mitigate the risks.
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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?
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.
Program may provide drugs with narrower labels an opportunity to gain preferred formulary status versus entrenched market leaders.