Abilify aripiprazole regulatory update

EMA’s CHMP recommended against expanding the label of Abilify aripiprazole from Otsuka to include treatment of schizophrenia in patients ages 13-14. Abilify is approved in patients ages >=15. CHMP said that data from 146 schizophrenic adolescents in a main study supporting the application were insufficient due to small patient numbers. The agency noted that about a fifth of the patients were ages 13-14. CHMP did find the data relevant for the patient population and recommended its inclusion in Abilify’s product information. Abilify is also approved to treat manic episodes in bipolar I disorder and to prevent manic episodes. ...