PARIS and LONDON -- 8 April 2008 -- The European Commission has granted marketing authorisation for aripiprazole (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 aripiprazole treatment.(1)
The approval decision follows a positive opinion adopted on February 21, 2008, by the European Committee for Medicinal Products for Human Use. The CHMP submission is based on data from 8 randomised clinical trials carried out in more than 2,400 people, which have confirmed the efficacy, safety and tolerability of 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 aripiprazole treatment.(2-9)
Aripiprazole received its first EU approval for the treatment of schizophrenia in 2004.
The commercial launch of aripiprazole in Bipolar I Disorder in the countries
of the European Union is expected to begin in the second quarter of 2008.
References
1. AbilifyŽ Summary of Product Characteristics.
2. Keck P, Marcus R, Tourkodimitris S et al. Am J Psychiatry. 2003;160:1651-1658.
3. Keck P, Calabrese J, McQuade R et al. J Clin Psychiatry. 2006;67:626-637.
4. Keck P, Calabrese J, McQuade R et al. J Clin Psychiatry. 2007;68:1480-1491.
5. Sachs G, Sanchez R, Marcus R et al. J Psychopharmacology. 2006;20:536-546.
6. Vieta E, T'joen C, McQuade R et al. Am J Psychiatry. Published online April 1, 2008.
http://ajp.psychiatryonline.org/.
7. Keck P.E, Sanchez R, Torbeyns A et al. APA 160th Annual Meeting, 2007. Poster CN138-135.
8. Dillenschneider A, Sanchez R, McQuade R.D, Torbeyns A. Second Meeting of West European Societies of Biological Psychiatry (WEBP), 2007. Poster CN138-162.
9. Vieta E, Bourin M, Sanchez R et al. Brit J of Psychiatry. 2005;187:235-242.
SOURCE: Bristol-Myers Squibb and Otsuka Pharmaceutical Co. Ltd
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