23 March 2017 - The EMA is expected to complete its review in second quarter of 2018.
Lundbeck and Otsuka today announce that the EMA has accepted for review a marketing authorisation application for brexpiprazole to treat schizophrenia in adults.
In both short-term and long-term clinical trials involving more than 3,000 patients, brexpiprazole has shown improvement in symptoms of schizophrenia and was generally well-tolerated in adult patients.