Posted by Michael Wonder on 18 Mar 2019
U.S. FDA accepts BLA filing of Aimmune Therapeutics’ AR101 for peanut allergy
18 March 2019 - If approved, AR101 will be the first medicine for this life-threatening condition.
Aimmune Therapeutics today announced that the biologics license application (BLA) for AR101 has been accepted for review by the U.S. FDA.
The FDA has informed Aimmune that the BLA will be reviewed under a twelve-month target review period, as measured from the January 2019 start date. As a consequence, review of the BLA may take until late January 2020. Aimmune is currently engaged in discussions with the FDA regarding the review timeline for the AR101 BLA. The FDA expects to convene an advisory committee meeting to discuss the application.
