Abilify aripiprazole regulatory update

EMA's CHMP issued a positive opinion to extend the indication for Otsuka's Abilify to include treatment of moderate to severe manic episodes in bipolar I disorder in adolescents ages >=13 years for up to 12 weeks. Abilify is approved in the EU to treat moderate to severe manic episodes in bipolar I disorder and prevent a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to Abilify treatment. The drug is also approved to treat schizophrenia in patients ages >=15 years. ...