Aimmune Therapeutics Inc.'s biologics license application for its peanut allergy drug has been accepted for review by the U.S. Food and Drug Administration.
The drug, called AR101, is intended to reduce risk of anaphylaxis — a potentially life-threatening allergic reaction that includes skin rash and difficulty breathing — in children ages 4 to 17 due to accidental exposure to peanut. AR101 received breakthrough designation from the FDA in 2015.
The application is based on a previous successful phase 3 trial, the Brisbane, Calif.-based company said in a March 18 press release.
According to Aimmune, the FDA's review of AR101 could take until January 2020, though Aimmune said it is discussing the review timeline with the agency.
The FDA, which had postponed work on the AR101 filing due to the 35-day government shutdown that began hours after Aimmune submitted its application, will also hold an advisory committee meeting for the potential product.