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H Lundbeck A/S and Otsuka Receive Positive CHMP Opinion for Abilify Maintena in Schizophrenia


Friday, 20 Sep 2013 07:15am EDT 

H Lundbeck A/S announced that Otsuka Pharmaceutical Co., Ltd. (Otsuka) and the Company have received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommending marketing authorization for Abilify Maintena (aripiprazole), an intramuscular (IM) depot formulation for the maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole. Abilify Maintena is a once-monthly injectable form of aripiprazole. It represents an alternative treatment option to address the need to reduce the risk of relapse (relative to placebo) in patients with schizophrenia. If approved by the European commission, Abilify Maintena would become the only dopamine D2 partial agonist in once-monthly injectable form for the maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole. 

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