EC clears Abilify for bipolar disorder

The European Commission has granted marketing authorization for Abilify (aripiprazole) 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 manic episodes responded to Abilify.

The approval is based on a February recommendation from the European Medicine Agency's (EMEA) Committee for Medicinal Products for Human Use 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 patients who experienced predominantly manic episodes and whose manic episodes responded to treatment. The agent received its first European approval for the treatment of schizophrenia in 2004. The commercial launch of Abilify in bipolar I disorder in the countries of the European Union is expected to begin in the second quarter.