20 March 2019 - - US-based biopharmaceutical company Aimmune Therapeutics, Inc.'s (NASDAQ: AIMT) Biologics License Application for AR101 has been accepted for review by the US Food and Drug Administration.

Aimmune is developing AR101 as a treatment to reduce the risk of anaphylaxis following accidental exposure to peanut.

The FDA granted AR101 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 AR101 BLA.

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

Aimmune's BLA is comprised of extensive clinical as well as chemistry, manufacturing and controls data.

Specifically, data from the pivotal phase 3 PALISADE trial of AR101, the largest and only successful phase 3 trial in peanut allergy, were published in the New England Journal of Medicine and demonstrated that AR101 treatment resulted in a significant increase in the amount of peanut protein tolerated compared to placebo.

The data suggest that AR101-treated patients could expect fewer and less severe reactions to accidental peanut exposures. Data from the phase 3 RAMSES trial confirmed the safety profile of AR101 first observed in the PALISADE study; both trials are part of the application submission.

Aimmune Therapeutics, Inc., is a biopharmaceutical company developing oral 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 desensitizing patients with defined, precise amounts of key allergens.

Aimmune's first investigational biologic product, AR101 is being developed as a treatment to reduce the risk of anaphylaxis following accidental exposures to peanut.

AR101 has received the FDA's Breakthrough Therapy Designation for the desensitization of peanut-allergic patients 4-17 years of age.

Aimmune expects to file for marketing approval of AR101 in Europe mid-2019.

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 mid-2019.