FDA accepts NDA filing for Lundbeck and Otsuka's brexpiprazole
The US Food and Drug Administration has accepted the filing for review of brexiprazole for the treatment of schizophrenia and as an adjunctive therapy in the treatment of major depression.
The drug, developed by Danish CNS drug specialist Lundbeck (LUN: CO) and Japanese drug maker Otsuka (TYO: 4768), has had its New Drug Application filed as of September 9.
The NDA is supported by seven placebo-controlled clinical Phase II and Iii studies in proposed indication, and includes data from more than 6,000 participants, of whom more than 5,000 received brexpiprazole.
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