BMS sees FDA approve Abilify for major depressive disorder

Bristol-Myers Squibb (BMS) and Otsuka Pharmaceutical have reported that the US Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Abilify (aripiprazole) for treatment in adults with major depressive disorder (MDD).

The FDA’s approval means Abilify is now the first available add-on treatment to antidepressant therapy (ADT) in adults with MDD.

Elliot Segal, executive vice-president of research and development at BMS, described the approval as a “reflection” of the company’s ongoing commitment to providing innovative therapies to those living with depression.

“We are committed to helping those who suffer from depression, one of the leading causes of disability in the United States and worldwide,” he confirmed.

The approval follows the release of results from two studies demonstrating significant improvement in depressive symptoms in adult patients with MDD who had experienced inadequate response to monotherapy with one or more ADTs in the current episode and then added Abilify.

Madhukar Trivedi, professor and chief of the mood disorders division of the Southwestern Medical School at the University of Texas, indicated that physicians would now have a new option they can add to patients’ antidepressant treatments.

Earlier this month, BMS and Otsuka announced that the FDA approved their sNDA Abilify in the treatment of schizophrenia in adolescents from 13 to 17 years.