Policy & Regulation
Aimmune Therapeutics Discusses AR101's Cost-Effectiveness and Demonstrated Clinical Benefits at ICER Meeting
13 June 2019 - - US-based biopharmaceutical company Aimmune Therapeutics, Inc. (NASDAQ: AIMT) held a presentation at the Institute for Clinical and Economic Review's Public Meeting reviewing the effectiveness and value of treatments for peanut allergy, the company said.
Aimmune is developing AR101, an investigational biologic drug for use in oral immunotherapy as a treatment to reduce the frequency and severity of allergic reactions following exposure to peanuts.
Cost per QALY, or quality-adjusted life year, measures the economic value of a health care intervention; the lower the cost per QALY, the higher the value of the treatment.
Using only clinical data from the landmark Phase 3 PALISADE trial, ICER found AR101 to be cost-effective well-below ICER's traditional threshold of USD 100,000-USD 150,000 per QALY.
Additionally, when factoring in the societal perspective, ICER found AR101 to be even more cost-effective compared to avoidance alone.
This early analysis does not include recent efficacy and safety data from the Phase 3 ARTEMIS trial or long-term patient reported outcomes.
Peanut allergy is one of the most common food allergies, affecting more than 1.6 m children and teens in the United States.1It can be a chronic and life-long condition, and symptoms from accidental exposures to peanut are often severe and potentially life-threatening.
The threat of a severe reaction dominates families' daily lives and interferes with their quality of life.
Stephen Tilles, M.D., Senior director of Medical Affairs, will represent Aimmune at TODAY's meeting. A board-certified allergist and immunologist and recent past president of the American College of Allergy, Asthma and Immunology (ACAAI), Dr. Tilles will discuss the critical need for rigorously developed, clinically tested, approved treatment for peanut allergy.
New data released at the 2019 European Academy of Allergy and Clinical Immunology (EAACI) Congress reinforce the clinical profile of AR101 and demonstrate improved safety and immunomodulation with continued longer-term daily treatment.
The FDA's Allergenic Products Advisory Committee will review Aimmune's Biologics License Application for AR101 at its meeting scheduled for September 13, 2019.
The FDA accepted the BLA for AR101 in March 2019 and previously informed Aimmune that completion of its review would be targeted by late January 2020. The FDA granted AR101 Fast Track Designation in September 2014 and Breakthrough Therapy Designation in June 2015 for peanut-allergic children and adolescents ages 4 to 17.
AR101 is a new, peanut-derived investigational oral biologic drug for use in oral immunotherapy in patients with peanut allergy. The drug, which is manufactured in accordance with current Good Manufacturing Practices, delivers a daily dose of peanut protein with a characterized protein profile, analysed to ensure consistent major allergen content.
The amount of active ingredient in each AR101 capsule is controlled to ensure minimal variability of allergen content across doses of a given strength.
AR101 is administered as an oral powder in graduated doses in pull-apart capsules or foil-laminate sachets. The contents are mixed thoroughly with a few spoonfuls of age-appropriate, unheated food of the patient's choice.
Aimmune Therapeutics 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 exposure to food allergens by desensitising patients with defined, precise amounts of key allergens.
Aimmune's first investigational biologic product, AR101, is being developed as a treatment to reduce the frequency and severity of adverse events following exposure to peanut.
The BLA for AR101 is under review by the US FDA, which in 2015 granted AR101 Breakthrough Therapy Designation for the desensitisation of peanut-allergic patients 4 to 17 years of age. Aimmune expects to file for marketing approval of AR101 in Europe in 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 in mid-2019.


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