BRISBANE, Calif.–(BUSINESS WIRE)–Aimmune Therapeutics, Inc. (Nasdaq:AIMT), a biopharmaceutical company developing treatments for potentially life-threatening food allergies, today announced that the Allergenic Products Advisory Committee (APAC) convened by the U.S. Food and Drug Administration (FDA) voted to support the use of AR101 (proposed trade name PALFORZIA in children and teens with peanut allergy.
PALFORZIA is a complex, biologic oral immunotherapy (OIT) candidate designed to reduce the incidence and severity of allergic reactions, including anaphylaxis, after accidental exposure to peanut in patients aged 4 through 17 years with a confirmed diagnosis of peanut allergy.
The APAC voted 7 to 2 that the efficacy data and 8 to 1 that the safety data, in conjunction with additional safeguards, are adequate to support the use of Palforzia.
Peanut allergy is one of the most common food allergies, affecting more than 1.6 million children and teens in the U.S. It can be a chronic and life-long condition, and reactions to peanut are severe and potentially life-threatening.ii For peanut-allergic individuals, the threat of a severe reaction interferes with their quality of life and has a daily effect on their families.
“We are very pleased that APAC voted in favor of Palforzia. This is an important day for the children, teens and their families who live with the profound daily impact of peanut allergy. We look forward to continuing to work with the FDA as we move towards a potential approval of Palforzia,” said Jayson Dallas, M.D., President and Chief Executive Officer of Aimmune. “We are immensely grateful to the entire food allergy community for helping us bring Palforziaone step closer to becoming the first FDA-approved treatment for any food allergy.”
As part of Aimmune’s original Biologics License Application (BLA) submission, the Company proposed a number of risk management measures in line with today’s Advisory Committee discussion which include: the requirement that the initial dose escalation and first dose of each dose-escalation level be administered in a facility equipped to treat systemic allergic reactions; documentation that patients have a prescription for injectable epinephrine prior to initiation of Palforzia; distribution of therapy through specialty pharmacies; and purposefully designed packaging so patients only receive their appropriate dose. Consistent with immunotherapies indicated to treat allergic conditions, Aimmune also proposed a Black Box warning within the product labeling in the original BLA submission.
“Patient safety has been central to us since the beginning of the Palforzia development program. We are gratified to be aligned with FDA in our focus on patient safety,” added Dr. Dallas. “We look forward to working with the Agency to finalize our proposals, which we believe will support the safe and appropriate use of Palforzia.”
Aimmune’s BLA seeking approval for Palforzia for the treatment of children and adolescents with peanut allergy currently is under review by the FDA, with a review action due date of late January 2020. The FDA granted Palforzia Fast Track Designation in September 2014 and Breakthrough Therapy Designation in June 2015 for peanut-allergic children and adolescents aged 4 to 17. In addition, the European Medicines Agency (EMA) is reviewing Aimmune’s Marketing Authorization Application (MAA) for Palforzia, which Aimmune submitted in June 2019. The FDA and EMA have conditionally accepted PALFORZIA as the trade name for AR101.
The BLA includes extensive clinical data from the largest and only phase 3 clinical trials to meet their primary endpoints in children and teens with peanut allergy, with over 1,000 patients enrolled. The results demonstrated that PALFORZIA treatment resulted in a significant increase in the amount of peanut protein tolerated compared to placebo, and that Palforzia-treated patients could expect fewer and less severe reactions to accidental peanut exposures, compared to placebo-treated patients, and significantly reduces the incidence and severity of allergic reactions, including anaphylaxis, after accidental exposure to peanut.