Otsuka and Lundbeck's schizophrenia drug Abilify Maintena approved in EU

Japan’s Otsuka Pharmaceutical (TYO: 4768) and partner Danish CNS drug specialist Lundbeck (LUN: CO) have received approval from the European Commission for their Abilify Maintena (aripiprazole), an intramuscular once-monthly injectable formulation for maintenance treatment of schizophrenia in adult patients stabilized with oral aripiprazole.

The once-monthly version of Otsuka’s $7 million-a-year standard Abilify was approved by the US Food and Drug Administration earlier this year (The Pharma Letter March 1). While some observers view the long-acting Abilify as primarily a life-cycle management advance for Otsuka with the approaching patent expiration of Abilify, there is evidence in clinical studies that long-acting antipsychotics have significant clinical impact for patient outcomes.

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