FDA Refuses to File Alkermes Application for Depression Candidate ALKS 5461

Alkermes acknowledged today that the FDA sent the company a “Refuse to File” letter in response to its New Drug Application (NDA) for the once-daily major depressive disorder candidate ALKS 5461—all but torpedoing the company’s plans to shepherd the drug toward approval this year and a commercial launch in 2019.ALKS 5461 is a once-daily, oral investigational medicine with a novel mechanism of action for the adjunctive treatment of major depressive disorder in patients wit