The US Food and Drug Administration has approved Forest Laboratories and Pierre Fabre's Fetzima for major depressive disorder.
Fetzima (levomilnacipran extended-release), a once-daily serotonin and norepinephrine reuptake inhibitor, has been given the green light based on Phase III studies of adults with MDD and statistically significant and clinically meaningful improvement in depressive symptoms across three doses (40, 80, and 120 mg).
Forest chief executive Howard Solomon says that "people respond differently to different medications" and the approval of Fetzima fulfills a "commitment to the millions of people living with MDD". The disorder affects almost 16 million adults in the USA every year.
Frederic Duchesne, president of the pharmaceutical division at Pierre Fabre, said "this marketing authorisation represents a key milestone" for the French drugmaker. He added that it "confirms our choice to make neuropsychiatry a strategic axis of our R&D efforts, next to oncology and dermatology".
Forest says it expects Fetzima to be available in the fourth quarter.