European Marketing Authorisation granted for Abilify in Bipolar I Disorder

Published: 8-Apr-2008
Regulatory

The European Commission has granted marketing authorisation for Abilify (aripiprazole) 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 European Commission has granted marketing authorisation for Abilify (aripiprazole) 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 approval decision follows a positive opinion adopted in February by the European Committee for Medicinal Products for Human Use. The CHMP submission is based on data from eight randomised clinical trials carried out in more than 2,400 people.

The commercial launch of Abilify in Bipolar I Disorder in the EU is expected to begin in the second quarter of 2008.

Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co. are collaborative partners in the development and commercialisation of Abilify, which was discovered by Otsuka Pharmaceutical Co. The drug received its first EU approval for the treatment of schizophrenia in 2004.

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