Otsuka’s schizophrenia drug filing U-turn amongst latest CHMP announcements

Otsuka Pharmaceutical Co. Ltd. has gone back on efforts to get its medicine, Asimtufii (aripiprazole), a long-acting maintenance treatment for schizophrenia, approved in Europe, after the EMA gave a provisional negative opinion. Europe’s Committee for Medicinal Products for Human Use (CHMP) criticized the firm’s decision not to compare the drug with the reference medicine (Abilify Maintena) – available in Europe – in the main study it conducted.