FDA Grants Priority Review to BMS’ sNDA for Abilify

The FDA has granted priority review to a supplemental new drug application (sNDA) for Otsuka Pharmaceutical’s Abilify used together with antidepressant therapy (ADT), Otsuka said in a joint statement with its partner, Bristol-Myers Squibb (BMS).

Two months ago, the two companies reported success treating adults with major depressive disorder with this combination of therapies in clinical trials. Abilify (aripiprazole) is already approved to treat schizophrenia. The priority review status means the FDA will try to complete it within six months.

The application is based on data from two six-week, double-blind, randomized, placebo-controlled, multi-site clinical trials. The studies enrolled 743 adult patients with major depressive disorder who had an inadequate response to monotherapy with one or more ADTs, and examined whether the use of “adjunctive” Abilify would help them.