FDA has immediate change of heart on depression drug filing

16 April 2018

It is not uncommon for drugmakers to imply that mistaken regulatory staff or a misunderstanding are the reason for development setbacks.

Those explanations might sometimes be met with a raised eyebrow, but in the case of Ireland-headquartered Alkermes (Nasdaq: ALKS), it seems that something along those lines has occurred in relation to its New Drug Application (NDA) for ALKS 5461.

Just two weeks ago, the company received a Refusal to File letter from the US Food and Drug Administration (FDA) in relation to the NDA, claiming there was insufficient evidence of overall effectiveness for the proposed indication of major depressive disorder (MDD) in patients with an inadequate response to standard antidepressant therapies. The agency said that additional clinical trials were needed prior to the resubmission of the NDA.

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