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FDA Complete Response Slows Down, But Won't Stop, Lundbeck's Serdolect

This article was originally published in The Pink Sheet Daily

Executive Summary

Agency comes to same conclusion as advisory committee: the risky schizophrenia drug could get approved if an appropriate patient group is identified.

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Lundbeck receives "complete response" from FDA for its schizophrenia drug

FDA sends Lundbeck a "complete response" letter for its schizophrenia agent Serdolect (sertindole), reaching the same conclusion as its advisory committee: the atypical antipsychotic could be approved if Lundbeck can identify an appropriate patient population. Sertindole is clearly efficacious, but it also clearly has significant cardiovascular risk. The letter, announced June 25, requested "additional data to best understand the appropriate patient population for which Serdolect could be made available." At its April 7 review, the Psychopharmacologic Drugs Advisory Committee voted that, despite its lack of safety, the antipsychotic could be used in an acceptably safe manner in some patient groups (1"The Pink Sheet," April 13, 2009). But the panel couldn't pinpoint who those patients are, and so far neither can Lundbeck and FDA. Serdolect's user fee date was May 15

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