27 December 2018 - - US-based biopharmaceutical company Aimmune Therapeutics, Inc. (NASDAQ: AIMT) has submitted a Biologics License Application to the US Food and Drug Administration for AR101, an investigational biologic oral immunotherapy for the treatment of peanut allergy in children and adolescents ages 4–17, the company said.

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.

Under the Prescription Drug User Fee Act (PDUFA), a Priority Review would target a review time of six months, compared to a standard review time of 10 months.

FDA informs the applicant of a Priority Review designation within 60 days of a BLA submission.

Aimmune Therapeutics is a biopharmaceutical company developing treatments for life-threatening food allergies.

The company's Characterized Oral Desensitization ImmunoTherapy (CODIT) approach is intended to provide meaningful levels of protection against allergic reactions resulting from accidental exposure to food allergens by desensitising patients with defined, precise amounts of key allergens.
Aimmune's first investigational biologic product using CODIT, AR101 for the treatment of peanut allergy, has received the FDA's Breakthrough Therapy Designation for the desensitization of peanut-allergic patients 4–17 years of age.

The company's regulatory filing for marketing approval of AR101 in the United States (submitted 4Q18) and Europe are based on data from the pivotal Phase 3 PALISADE clinical trial of AR101, which in 4–17-year-old subjects met its primary and key secondary endpoints, and additional ongoing and completed AR101 clinical trials.

Aimmune has filed an IND application for its second product, AR201, for the treatment of egg allergy and intends to start a randomised Phase 2 clinical trial in the first half of 2019.