Alkermes PLC (NASDAQ: ALKS) saw its shares drop early on Monday after the company announced that it received a letter from the U.S. Food and Drug Administration (FDA). Specifically, the firm received a Refusal to File letter regarding its New Drug Application (NDA) for ALKS 5461 for the treatment of major depressive disorder (MDD) in patients with an inadequate response to standard antidepressant therapies.
Upon its preliminary review, the agency has taken the position that it is unable to complete a substantive review of the regulatory package, based on insufficient evidence of overall effectiveness for the proposed indication, and that additional well-controlled clinical trials are needed prior to the resubmission of the NDA for ALKS 5461.
Additionally, the FDA has requested that Alkermes conduct of a bioavailability study to generate additional bridging data between ALKS 5461 and the reference listed drug, buprenorphine.
It’s worth pointing out that Alkermes strongly disagrees with the FDA’s conclusions and plans to appeal the FDA’s decision. The company intends to seek immediate guidance, including requesting a Type A meeting with the FDA, to determine appropriate next steps and what additional information may be required to resubmit the NDA.
Richard Pops, CEO of Alkermes, commented:
We are extremely disappointed with this decision and the implications for patients in the U.S. suffering from major depressive disorder, a serious disease where there is a clear and urgent need for new treatment options for patients and their families. We strongly believe that the clinical development program, including data from more than 1,500 patients with MDD, provides substantial evidence of ALKS 5461’s consistent antidepressant activity and a favorable benefit-risk profile.
Shares of Alkermes closed most recently at $57.96 but opened near $46.75 on Monday. The consensus analyst price target is $62.45, and the 52-week trading range is $46.43 to $71.22.