CHMP OK's new indications for Abilify

US drug major Bristol-Myers Squibbs and Japanese drugmaker Otsuka say that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion on Abilify (aripiprazole), recommending its approval for 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 condition responded to Abilify. The agent received its first European approval, for the treatment of schizophrenia, in 2004.

Based on this positive opinion, the companies expect the European Commission to issue its decision on marketing authorization for Abilify in April. 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 the agent in the recommended indications, the firms noted. In fourth-quarter 2007, global sales of the drug totaled $462.0 million.