Home Challenging Results TrialWatch: FDA Rejects Alkermes Depression Drug Asking for More Data

TrialWatch: FDA Rejects Alkermes Depression Drug Asking for More Data


TrialSite News reports that the FDA has rejected biotech Alkermes depression drug “unpersuaded” by the trial results.  Apparently, the agency has requested for more data pointing toward evidence of effectiveness for ALKS 5461. Alkermes (NASDAQ: ALKS) stock price dipped by 5%.  In the sponsor’s press release, they noted that the FDA sent them a Complete Response Letter (CRL) regarding its New Drug Application (NDA) for ALKS 5461 for the adjunctive treatment of major depressive disorder (MDD).  The CRL states that the FDA is unable to approve the ALKS 5461 NDA in its present form and is requesting additional clinical data to provide substantial evidence of effectiveness of ALKS 5461 for the adjunctive treatment of MDD. Alkermes plans to meet with the FDA to discuss the contents of the CRL and potential next steps for ALKS 5461. This interaction with the Agency will inform whether there is a viable path forward for the ALKS 5461 program. The NDA submission for ALKS 5461 was 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.


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