Alkermes Says U.S. FDA Accepts Review Of NDA For ALKS 5461 - Quick Facts

(RTTNews) - Alkermes plc (ALKS) announced Monday that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for ALKS 5461. FDA's target action date for the ALKS 5461 NDA is January 31, 2019.

ALKS 5461 is a novel, once-daily, oral investigational medicine for the adjunctive treatment of major depressive disorder (MDD) in patients with an inadequate response to standard antidepressant therapies.

FDA's acceptance of the ALKS 5461 NDA and rescission of the Refusal to File letter issued March 30, 2018 follows productive interactions with the Agency in which Alkermes clarified certain aspects of the NDA submission.

No additional data or analyses were submitted by Alkermes to FDA after its refusal in late March.

The NDA filing for ALKS 5461 is based on results from a clinical efficacy and safety package with data from more than 30 clinical trials and more than 1,500 patients with MDD.

Throughout the clinical development program, ALKS 5461 demonstrated a consistent profile of antidepressant activity, safety and tolerability in the adjunctive treatment of MDD.