Posted by Michael Wonder on 29 Jun 2019
Aimmune submits marketing authorisation application to EMA for AR101 for peanut allergy
28 June 2019 - Aimmune Therapeutics today announced that it has submitted a marketing authorisation application to the EMA for AR101, an investigational biologic oral immunotherapy to reduce the frequency and severity of allergic reactions following exposure to peanuts in children and adolescents ages 4 to 17.
The submission includes extensive data from the only Phase 3 clinical trial program to meet the primary endpoints in children and teens with peanut allergy. This program included well over 1,000 patients enrolled into the PALISADE, RAMSES and ARTEMIS trials.
The pivotal European Phase 3 ARTEMIS study, which represents a key component of the submission, reinforced the consistent clinical profile of AR101 after six months of dose escalation and a three-month therapeutic dosing phase.
