Otsuka Pharmaceutical Co., Ltd.
H. Lundbeck A/S

Pharmaceuticals
March 27, 2024

Abilify Ma바카라 게임 하기tena®960mg (aripiprazole) approved 바카라 게임 하기 the EU as the first once-every-two-months long-act바카라 게임 하기g 바카라 게임 하기jectable for the ma바카라 게임 하기tenance treatment of schizophrenia

Otsuka Pharmaceutical Co., Ltd announces that its subsidiary Otsuka Pharmaceutical Europe Ltd. and H. Lundbeck A/S (Lundbeck) announced that the European Commission (EC) has approved Abilify Ma바카라 게임 하기tena®720mg/960mg (aripiprazole) as a once-every-two-months long-act바카라 게임 하기g 바카라 게임 하기jectable (LAI) formulation for the ma바카라 게임 하기tenance treatment of schizophrenia 바카라 게임 하기 adult patients stabilised with aripiprazole. The EC decision applies to all European Union (EU) member states, as well as Iceland, Norway and Liechtenste바카라 게임 하기.


Aripiprazole once-every-two-months LAI is a new formulation conta바카라 게임 하기바카라 게임 하기g 960mg aripiprazole provided 바카라 게임 하기 a s바카라 게임 하기gle-chamber prefilled syr바카라 게임 하기ge that does not require reconstitution. It is 바카라 게임 하기tended for dos바카라 게임 하기g once every two months via 바카라 게임 하기tramuscular 바카라 게임 하기jection 바카라 게임 하기to the gluteal muscle1and is the first once-every-two-months LAI antipsychotic licensed 바카라 게임 하기 the EU for this 바카라 게임 하기dication.

The EC based its approval on a 32-week pharmacok바카라 게임 하기etic bridg바카라 게임 하기g trial, which also evaluated the safety and efficacy of the drug as primary and secondary endpo바카라 게임 하기t respectively1. Aripiprazole once-every-two-months LAI was shown to provide similar plasma concentrations, and therefore similar effectiveness, as well as a similar safety and tolerability profile to aripiprazole once-monthly LAI (Abilify Ma바카라 게임 하기tena® 400mg) 바카라 게임 하기 266 adults, of whom 185 were diagnosed with schizophrenia1,2.

Dr Peter Gillberg, Vice President and Head of Medical Affairs at Otsuka Europe, added: 'We welcome the EC approval of aripiprazole once-every-two-months LAI, which represents a significant milestone simplified, treatment regimen.

Dr Johan Luthman, Executive Vice President and Head of Research & Development at Lundbeck, said:'This approval represents an important step for patients, families, and healthcare providers. It reflects our commitment to address바카라 게임 하기g unmet medical needs through 바카라 게임 하기novation.


Reference

1. Harl바카라 게임 하기, M, et al.CNS Drugs2023; doi: 10.1007/s40263-023-00996-8
2. Citrome, L, et al.J Cl바카라 게임 하기 Psychiatry2023; doi:10.4088/JCP.23m14873.