FDA flip-flops on Alkermes' drug application

Two weeks ago, it looked like the hopes for Alkermes’ ALKS 5461 receiving approval would rely on returning to the clinic to undergo the lengthy process of gathering more data on the drug, after it received a Refuse to File letter from the FDA.

Now, the agency has switched up its position, catching everyone off guard with its decision to accept for review Alkermes’ NDA for ALKS 5461.

As the FDA is not compelled to provide a reason for this about-face, the only information coming out of the decision is from Alkermes.

In a press release, it suggested that the "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."

It is unlikely the full story will ever emerge but it certainly seems odd given that the FDA’s initial RTF was not met by much surprise; ALKS 5461 has had a rocky development history, it was developed as an adjunctive treatment for major depressive disorder but failed to hits its primary endpoint in two Phase 3 trials.

It eventually succeeded in one Phase 3 trial and suggested that its previous failures were down to higher-than-expected placebo responses – not an uncommon feature of trials looking into treatments for depression.

It initially seemed as though the FDA wasn’t convinced by this argument, asking for more trial data before it could accept the biotech’s NDA.

However, this isn’t the first time that the FDA, under Commissioner Scott Gottlieb, has made moves to reverse decisions previously agreed. Eli Lilly, for example, were allowed another crack of the whip to gain approval for its potential rheumatoid arthritis drug, baricitinib.

The agency has certainly come under pressure to speed up approvals from the administration and it appears that it is taking the message seriously enough that it is prepared to face greater scrutiny by undermining previous decisions.

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