Abilify Granted Priority Review Status as Major Depression Treatment

Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. announced yesterday that the FDA has accepted for filing and granted a Priority Review for the supplemental New Drug Application (sNDA) of Abilify (aripiprazole) for the treatment of adults with major depressive disorder as adjunctive to antidepressant therapy (ADT).

Priority Review status is given if a product, if approved, would be a significant improvement over currently marketed products, including non-drug products and therapies in the treatment, diagnosis or prevention of a disease. The FDA goal for reviewing a drug with Priority Review is six months.

This sNDA is based on data from two six-week, double-blind, randomized, placebo-controlled, multi-center trials evaluating the use of adjunctive Abilify in adult patients with a primary diagnosis of major depressive disorder who had an inadequate response to antidepressants alone.

Abilify works by partially activating dopamine receptors in the brain. It is currently approved for the treatment of bipolar disorder and schizophrenia. If it receives approval for the new application, Abilify could be used in conjunction with an antidepressant to enhance its therapeutic effect.