Oct 10 2013
Alkermes plc (NASDAQ: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track status for ALKS 5461 for the adjunctive treatment of major depressive disorder (MDD) in patients with an inadequate response to standard therapies. Fast Track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and with the potential to address an unmet medical need.
"We are extremely pleased to have been conferred Fast Track status for ALKS 5461 as we believe that ALKS 5461 may represent an important option for the treatment of major depressive disorder," said Elliot Ehrich, Chief Medical Officer of Alkermes. "This designation supports our position that there is a clear and compelling need for a novel mechanism for the treatment of depression."