[Updated, 11:25 am ET, see below] The partial U.S. government shutdown has just had its first tangible effects on the potential approval of a new drug: The FDA review of a peanut allergy treatment from Aimmune Therapeutics (NASDAQ: [[ticker:AIMT]]) has been delayed.
In a regulatory filing posted late Wednesday, Aimmune, of Brisbane, CA, said that because of the shutdown, the FDA won’t begin a review of AR101, its experimental immunotherapy for peanut allergies, as planned. The FDA won’t start the review until the shutdown “and lapse in appropriations” has ended, Aimmune said in the filing.
The news marks the first reported instance of the FDA being unable to fulfill its review timelines since the shutdown began. It is a harbinger of things to come if the government impasse drags on.
Aimmune filed for FDA approval of AR101 on Dec. 21, the day before the shutdown began. The impasse has since dragged on for more than three weeks, becoming the longest in U.S. history. The potential ripple effects for biotech are significant. The FDA is running out of user fees, paid by companies, to fund the regulatory review of drugs and medical devices. Last week, commissioner Scott Gottlieb wrote that the agency is shifting those user fees from pre-market drug reviews to post-market safety surveillance. That means, in the near-term, there could be delays in various drug reviews. Gottlieb tweeted on Jan. 5 that the program that reviews new drugs will likely run out of cash in about a month.
[Updated with analyst comment] “With the FDA unable to accept new user fees and existing carryover funds reportedly only expected to last for several more weeks, we expect drug manufacturers could face near-term regulatory gridlock and the potential for a backlog of delayed filings, meetings, and regulatory decisions that could extend even beyond the end of the shutdown,” wrote RBC Capital Markets analyst Brian Abrahams, in a research note.
Abrahams added that he expects to see fewer speedy, “priority” reviews, more standard reviews, and perhaps even more drug rejections as “existing personnel at the FDA prioritize food/drug safety monitoring over new approvals.”
Additionally, biotech that filed for IPOs during the shutdown—Alector, Poseida Therapeutics, Gossamer Bio, and more—could also be left in limbo as thousands of SEC workers are furloughed and not reviewing or approving regulatory filings.
Aimmune’s drug is an oral biologic—taken via a capsule or packet with food—that exposes patients to controlled doses of peanut protein. The idea is by increasing the dose over time, patients become less likely to develop severe reactions. It’s meant to be more convenient and safe than other injectable or food extract peanut allergy treatments. The delay of its review is a stinging setback for Aimmune, which saw DBV Technologies (NASDAQ: [[ticker:DBVT]]) withdraw an approval application for a rival peanut allergy treatment just a day before the company filed for approval of AR101. DVB plans to re-file its application, though it hasn’t said when.
Here’s more on the shutdown, Aimmune, and peanut allergy treatments.
