Posted by Michael Wonder on 22 Dec 2018
Aimmune Therapeutics submits BLA to FDA for AR101 for the treatment of peanut allergy in children and adolescents ages 4–17
21 December 2018 - Aimmune Therapeutics today announced that it has submitted a biologics license application to the U.S. FDA for AR101, an investigational biologic oral immunotherapy for the treatment of peanut allergy in children and adolescents ages 4–17.
The FDA granted AR101 fast track designation for peanut allergy in September 2014 and breakthrough therapy designation for peanut allergy in ages 4–17 in June 2015.
Aimmune’s BLA submission includes data from the pivotal Phase 3 PALISADE trial of AR101, recently published in the New England Journal of Medicine; the PALISADE follow-on trial ARC004; and the Phase 3 RAMSES trial, which confirmed that the safety profile of AR101 was consistent with that observed in the PALISADE trial; as well as extensive data on AR101 chemistry, manufacturing and controls.
