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news.Bristol-Myers Squibb and Otsuka have reported that the European Commission has granted marketing authorization for Abilify in the treatment of moderate to severe manic episodes in bipolar I disorder and for the prevention of a new manic episode in patients who experienced predominantly manic episodes and whose manic episodes responded to Abilify treatment.
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The approval decision follows a positive opinion adopted on 21 February 2008 by the European Committee for Medicinal Products for Human Use (CHMP). The CHMP submission is based on data from eight randomized clinical trials carried out in over 2,400 people, which have confirmed the efficacy, safety and tolerability of Abilify in the treatment of moderate to severe manic episodes in bipolar I disorder and for the prevention of a new manic episode in patients who experienced predominantly manic episodes and whose manic episodes responded to Abilify treatment.
The commercial launch of Abilify in bipolar I disorder in the countries of the EU is expected to begin in the second quarter of 2008.