FDA approves Abilify sNDA for major depressive disorder

This supplemental new drug application (sNDA) approval is based on results from two six-week, double-blind, randomized, placebo-controlled, multicenter studies. The results demonstrated significant improvement in depressive symptoms in adult patients with a primary diagnosis of major depressive disorder who had experienced an inadequate response to monotherapy with one or more antidepressant therapies in the current episode and then added Abilify to their treatment regimens.

Elliott Sigal, executive vice president, chief scientific officer and president, R&D, Bristol-Myers Squibb, said: “We are committed to helping those who suffer from depression, one of the leading causes of disability in the US and worldwide. This approval is a reflection of our ongoing commitment to provide innovative therapies, such as Abilify, to help adults living with depression.”