Alkermes announced the initiation of its rolling submission of a New Drug Application (NDA) to the FDA, seeking marketing approval of ALKS 5461, a once-daily, oral investigational medicine with a novel mechanism of action, for the adjunctive treatment of major depressive disorder (MDD). The company expects to complete the submission of the NDA for this Fast Track designated medicine by year-end 2017.
“The initiation of the rolling submission for ALKS 5461 is an important first step in the registration process for ALKS 5461, as we work to bring this potential new medicine to patients suffering from major depressive disorder. ALKS 5461 represents a novel mechanism of action for the treatment of MDD, a condition for which millions of patients in the U.S. do not achieve an adequate response to standard antidepressant therapies,” stated Elliot Ehrich, M.D., Executive Vice President, Research and Development of Alkermes. “We expect to complete the submission of the NDA by year-end 2017 and will continue to collaborate closely with the FDA as we work expeditiously toward making ALKS 5461 available to patients and their healthcare providers.”
The FDA Fast Track designation is designed to facilitate the development and expedite the review of medicines that are intended to treat serious conditions and address unmet medical needs. Fast Track designation allows for the submission of completed portions of the NDA on a rolling basis as well as eligibility for Priority Review. At a pre-NDA interaction with FDA in July, the company and FDA agreed upon the proposed content and timing of the ALKS 5461 NDA submission.