Otsuka Pharmaceutical Europe Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announced that the European Commission (EC) has approved Abilify Maintena®? 960 mg (aripiprazole) as a once-every-two-months long-acting injectable (LAI) formulation for the maintenance treatment of schizophrenia in adult patients stabilised with aripiprazole. The EC decision applies to all European Union (EU) member states, as well as Iceland, Norway and Liechtenstein.

Aripiprazole once-every-two- months LAI is a new formulation containing 960 mg aripiprazole provided in a single-chamber prefilled syringe that does not require reconstitution. It is intended for dosing once every two months via intramuscular injection into the gluteal muscle and is the first once- every-every-two-months LAI antipsychotic licensed in the EU for this indication. The EC based its approval on a 32-week pharmacokinetic bridging trial, which also evaluated the safety and efficacy of the drug as primary and secondary endpoint respectively.

About schizophrenia Schizophrenia is a chronic, disabling and progressive mental illness, characterised by delusions, hallucinations, and disordered cognition which may occur at varying intervals between periods of relative symptomatic stability. Schizophrenia affects approximately 24 million people, or 1 in 300 people (0.32%) worldwide. Onset is most often during late adolescence and the twenties, and onset tends to happen earlier among men than women.

Schizophrenia is frequently associated with significant distress and impairment in personal, family, social, educational, occupational, and other important areas of life. It is one of the top 15 leading causes of disability worldwide.