Lundbeck, Otsuka Pharma say CHMP issues positive opinion for label update of Abilify Maintena

3 February 2016

Danish CNS specialist Lundbeck (LUN: CO) and Otsuka Pharmaceutical Europe (TYO: 4768) on Wednesday said the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion for a label update of Abilify Maintena (aripiprazole) to describe new clinical data for the treatment of acutely relapsed adults with schizophrenia.

The companies, in a joint statement said, the opinion was based on Abilify Maintena demonstrating efficacy, tolerability and safety in a 12-week study in acutely relapsed adults with schizophrenia.

The application was submitted to the European Medicines Agency and the assessment started end November 2015.

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