- The ongoing partial shutdown of the U.S. government has temporarily derailed biotech Aimmune Therapeutics' bid to win approval for an experimental peanut allergy drug, preventing the Food and Drug Administration from beginning review of the company's application.
- Aimmune had moved quickly to file its application for the drug, called AR101, a day before large parts of the U.S. government shuttered due to a funding lapse. Even so, the FDA has now notified Aimmune it will not be able to initiate review of the drug, the biotech said in a regulatory filing Monday.
- FDA review of drugmaker applications for most new product approvals is funded through industry user fees. Due to the shutdown, however, the agency has been unable to accept new fees, while other activities have been sharply curtailed. On Monday, FDA chief Scott Gottlieb tweeted that the regulator has about five weeks' worth of carried-over user fees to fund work by its centers for drugs and biologics.
Aimmune has found itself caught on the wrong side of the government shutdown, despite a scramble to avoid this very outcome.
Last week, Aimmune CEO Jayson Dallas indicated the company successfully submitted its Biologics License Application and associated fees on Dec. 21 for AR101, a peanut-derived immunotherapy. The government partially shut down the next day.
That punctuality proved for naught, as the shutdown's effects have consigned Aimmune's application to regulatory limbo until the federal government reopens. Once that occurs, the FDA has informed Aimmune it would begin review of the BLA.
Gottlieb took to Twitter again Tuesday morning to offer further explanation of how the agency is handling new drug reviews, but created some fresh confusion about Aimmune's application in the process.
"We're still reviewing products submitted as part of user fee programs," he wrote in a tweet. "But blood products and allergenic products are not covered by user fee programs. So routine review activity ceased related to new products in these categories."
Aimmune has said it paid fees to the FDA as part of its application for AR101, raising questions over whether Gottlieb's comments applied to AR101.
Setting aside any particular matter specific to any one company, sometimes it’s the case that companies will try to file under pathways that aren’t open to them. Allergenic-type products only meet criteria to fall outside the allergenic category in very specific circumstances.— Scott Gottlieb, M.D. (@SGottliebFDA) January 15, 2019
Aimmune did not return multiple requests for comment from BioPharma Dive before publication.
Shares in the biotech, which had fallen 5% Monday, dropped by a similar amount again in Tuesday morning trading.
Aimmune isn't the only biotech holding its breath for an end to the shutdown. Both AbbVie and Alkermes submitted applications for new drug approvals in the days running up to parts of the government closing. It's not clear if the FDA has begun reviewing those submissions.
And more drugmakers may experience delays as well if the shutdown continues.
Jazz Pharma, Recro Pharma, Sage Therapeutics and Sanofi all await decisions on new drug approvals in March, for example.
On Friday, a group of Senate Democrats wrote a letter to the agency requesting further information on the shutdown's impact, raising concerns of a potential backlog in medical product reviews once the government reopens.
"The agency will likely receive a large influx of applications from drug and device makers following the conclusion of the shutdown, requiring the agency to triage review activities and probably causing a backlog in the approval process," the group of 34 senators wrote.