FDA grants priority review of drug for bipolar pre-teens

NEW YORK Otsuka Pharmaceuticals and Bristol-Myers Squibb have been granted a priority review of the supplemental drug application for the antipsychotic drug Abilify, for pediatric patients with bipolar I disorder, manic or mixed episodes with or without psychotic features, according to Web site abcmoney.

A little over a week ago, the companies received approval from the FDA for the drug to treat schizophrenia in adolescents aged 13 to 17. The approval comes as a result of a clinical study that assessed the safety and efficacy of the drug in 396 pediatric patients with bipolar I disorder over a 30-week timeframe.

Over 12.5 million prescriptions have been written as of June 2007 for Abilify, according to IMS.

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