Aimmune Therapeutics has confirmed that the government shutdown will delay the FDA’s review of AR101, its oral immunotherapy for peanut allergy.
In an SEC filing, Aimmune said it had been notified by FDA that it would not start its review of AR101 as a direct consequence of the shutdown and the “lapse in appropriations,” in other words the gap caused by the agency’s inability to raise further funding through user fees.
The review of the Biologics License Application (BLA) for AR101 will not start until the shutdown and lapse in appropriations has ended, says the notice. Aimmune is hoping that AR101 will become the first peanut allergy therapy to be approved, addressing a market that analysts at Stifel have suggested could be worth $3 billion.
Aimmune told FierceBiotech last week that it had made a conscious effort to file its BLA and pay its user fee well ahead of the shutdown on Dec. 21 in the hope of keeping the program’s review timescale on track. It had been hoping for confirmation of priority review designation—which would give AR101 a six-month rather than 10-month review—within 60 days of filing.
The biotech is also trying to start mid-stage trials of its egg allergy immunotherapy but has acknowledged that this will also be delayed until the fiscal 2019 appropriations window opens, as will discussions it needs to have with the regulator about a planned multinut allergy treatment.
Aimmune is just one company that has made a public statement about a delayed program as a result of the shutdown, but as the impasse continues there are likely to be many more affected as the FDA refocuses its dwindling resources on critical public health activities.
A report in STAT notes that at least 10 pharma companies are expecting decisions from the agency in March—after the available funding runs out—and suggests that delays could create a backlog of work that will hold up other regulatory decisions after the shutdown comes to an end.
Lawmakers are starting to get concerned about the impact of the shutdown on the FDA’s operations, and a few days ago 34 Democrats led by Senate Health, Education, Labor and Pensions (HELP) committee ranking member Patty Murray have sent a letter to Gottlieb requesting information about the shutdown’s impact the safety of the nation’s food supply and approval of medical products.
In particular, they want to know how FDA is reducing oversight of food facilities, how medical device approval might be hindered, and whether the agency is taking steps to address the financial hardships of furloughed employees.
“While we appreciate the efforts of the agency and the tireless work of your staff to help mitigate the impact of the shutdown on the public health, we remain deeply concerned about the halt of vital regulatory and compliance activities at FDA,” they write.
“FDA plays a crucial role in ensuring the health and safety of families across the country, and it’s important we fully understand how the ongoing shutdown has impacted its ability to fulfill that role.”