BRIEF—Otsuka seeks broader Abilify Maintena label in Japan

Japanese drugmaker Otsuka (TYO: 4768) has filed an application in its home country for the additional indication of suppression of recurrence and relapse of mood episodes in bipolar disorder for Abilify Maintena (aripiprazole), a long-acting injectable suspension.

The antipsychotic first received regulatory approval in the USA and European Union in 2013 for the treatment of schizophrenia, and it was approved in this indication in Japan in 2015.

Abilify Maintena received approval as a maintenance therapy for bipolar I in the USA and Canada in 2017.