US FDA accepts for review Otsuka and Lundbeck’s sNDA for Abilify Maintena

Danish CNS specialist Lundbeck (LUND: C) and the US subsidiary of Japan’s Otsuka Pharmaceutical (TYO: 4768) revealed that the US Food and Drug Administration has accepted for review a supplemental New Drug Application (sNDA) for the proposed expanded labeling of Abilify Maintena (aripiprazole) for extended-release injectable suspension to support broader use of the drug for treatment of patients in the acute phase of schizophrenia.

Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target date of December 7, 2014 to complete its review.

The sNDA submission was based on a 12-week study of patients with schizophrenia hospitalized and experiencing an acute exacerbation of symptoms. The study demonstrated efficacy on the primary endpoint of Positive and Negative Syndrome Scale (PANSS) total score (p<0.0001).