FDA accepts BLA for AR I0I to reduce the risk of anaphylaxis

Aimmune Therapeutics, Inc. announced that the Biologics License Application (BLA) for AR 101 has been accepted for review by the FDA. Aimmune is developing AR 101 as a treatment to reduce the risk of anaphylaxis following accidental exposure to peanut. The FDA granted AR 101 Breakthrough Therapy Designation in June 2015 for peanut-allergic children and adolescents ages 4-17, which was preceded by the granting of Fast Track Designation in September 2014. Both of these programs support expedited review of new drugs and biologics.

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 AR 101 BLA. The FDA expects to convene an advisory committee meeting to discuss the application.