- A peanut allergy drug developed by Aimmune Therapeutics has finally been accepted for review by the Food and Drug Administration, after delays caused by the 35-day U.S. government shutdown temporarily derailed the company's application.
- Regulators assigned the oral therapy, known as AR101, the standard 12-month review period for allergenic products. An approval decision could therefore come by January 2020 — about a year after Aimmune filed AR101. Notably, the FDA has granted the drug both Fast Track and Breakthrough Therapy designations, which could help speed review. There will be an advisory committee convened, Aimmune said.
- Aimmune's submission is based on data from a pair of Phase 3 trials testing AR101. Piper Jaffray analyst Christopher Raymond estimates the drug could fetch $69 million in revenue in 2020 and more than $400 million by 2022.
Despite squeaking in its Biologics License Application for AR101 on Dec. 21 and paying a user fee, Aimmune still got caught up in delays caused by the five-week U.S. government shutdown, which began Dec. 22.
Aimmune executives had thought AR101 would be covered under the Prescription Drug User Free Act agreement, by which the FDA can continue drug reviews during a funding lapse.
However, Aimmune revealed to investors in mid-January that the FDA hadn't begun its review, and wouldn't until the shutdown ended. Tweets the following day from FDA Commissioner Scott Gottlieb suggested this was because the drug was an allergenic product and so not covered by a user fee program. Aimmune's stock consequently fell 12%.
Now, two months after that regulatory surprise, Aimmune is back on track. But it doesn't appear the company has secured the expedited review that CEO Jayson Dallas recently indicated he hoped would be granted.
A launch in the fourth quarter of 2019 is possible, though perhaps unlikely. The 12-month period assigned to AR101 is around the usual length of time allocated for a non-PDUFA therapeutic, but it does mean that there may not be an FDA decision made until early 2020.
"We are working with the FDA to complete their review as expeditiously as possible given that there are currently no approved medicines for peanut allergy," Dallas said in a March 18 statement.
Investors, already frustrated with the delays surrounding AR101, didn't take too kindly to the revised timeline. By Monday's market close, Aimmune's share price had fallen nearly 5% from Friday's close. Shares declined a further 2.5% in value on Tuesday morning.
Aimmune, though, still has a chance at beating to market its nearest competitor. DBV Technologies withdrew the application for its peanut allergy treatment, Viaskin Peanut, voluntarily in December, after confirming that the submission lacked "sufficient detail regarding data on manufacturing procedures and quality controls."
Viaskin Peanut is expected to be resubmitted by the third quarter 2019, with a potential launch in early 2021.