BRIEF—EMA to review of aripiprazole 2-month injectable for maintenance treatment of schizophrenia

Otsuka Pharmaceutical Europe and Lundbeck today announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for aripiprazole as a 2-month ready-to-use (RTU) long-acting injectable (LAI) for the maintenance treatment of schizophrenia in adult patients stabilised with aripiprazole.

Aripiprazole 2-month RTU LAI is a new formulation provided in a single chamber prefilled syringe that does not require reconstitution.

It is intended for dosing every two months via intramuscular injection into the gluteal muscle, in the same patient population as indicated for Abilify Maintena (aripiprazole once-monthly LAI).

If approved, aripiprazole 2-month RTU LAI would be the first 2-month LAI antipsychotic licensed in the EU indicated for the maintenance treatment of schizophrenia in adult patients stabilised with aripiprazole.