Regulatory

In a stunning about face, the FDA is now welcoming the new drug application from Alkermes it rejected 2 weeks ago

Somebody at the FDA just got a rude wake up call.

Just two weeks after the FDA invited Wall Street to pummel Alkermes $ALKS by refusing to even accept its applications for the depression drug ALKS-5461, the biotech says that the agency has suddenly decided to simply change its mind.

According to Alkermes, the stunning about face came after the company “clarified certain aspects of the NDA submission. No additional data or analyses were submitted by Alkermes to FDA.”

Alkermes shares immediately shot up 20%, regaining $1.3 billion of its market cap. But it couldn’t hold on to that, though, dropping to an 8% gain mid-morning. Its PDUFA date was set for January 31, 2019.

Alkermes said in early April that the FDA was demanding that the company conduct additional trials of 5461, a move that hammered the company’s share price as analysts pondered the years of work and expense in taking another risky shot at gaining positive clinical data.

The company was throwing the dice on its application when it first filed, hoping to persuade the FDA that its one positive pivotal study along with additional data would outweigh the two failed trials that tarnished the drug. That would not have met the agency’s long established standard for two positive studies, but as I’ve written earlier the FDA has been ratcheting down its hurdles to get more drugs approved.

The change up marks another sign of the dramatic shift in the FDA’s stance on drug applications and its standards for reviews, raising some major questions for the industry as well as consumers. Since Scott Gottlieb became commissioner in 2017 after he was nominated for President Donald Trump with a mandate to speed new drug approvals, the agency reversed itself on three key drug rejections for Eli Lilly, TherapeuticsMD and Amicus, waving off its earlier demands for more work.

None of these reversals carry a guarantee of an approval, but they do reflect changes in direction that all drug developers will pay close attention to.

Barclays summed it up this way:

Given the political nature of the current FDA administration, we could see a scenario where normal-course review for ALKS-5461 felt more “appropriate” than controversy raised by an RTF, especially considering the product’s prior Fast Track designation and medical need for innovation within the indication. However, we continue to feel ALKS is long from out of the woods on ALKS-5461 and will need to continue to engage with FDA during review with potential for the ongoing Phase 3 to play a role in any potential approval or review decision.

Who at the FDA overruled the decision to reject Alkermes’ drug application? And why?

The agency, bound by strict rules of silence when it comes to commenting on companies and drugs outside a carefully regulated set of public disclosures, declined comment — as they always do.

Craig Hopkinson

Craig Hopkinson, chief medical officer and senior vice president of medicines development and medical affairs at Alkermes had this to say:

“We will continue to engage with the FDA throughout the review process, as we work to bring this important medicine to patients.”


Image: Alkermes CEO Richard Pops at an Endpoints event, January 2017. ENDPOINTS NEWS


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