Lundbeck receives "complete response" from FDA for its schizophrenia drug
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
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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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 (Also see "FDA Complete Response Slows Down, But Won't Stop, Lundbeck's Serdolect" - Pink Sheet, 25 Jun, 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. |