FDA Allergenic Products Advisory Committee votes to support the use of Palforzia (AR101) for peanut allergy.- Aimmune Therapeutics Inc.

Aimmune Therapeutics, Inc. announced that the Allergenic Products Advisory Committee (APAC) convened by the FDA voted to support the use of AR 101 (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. As part of Aimmune’s original Biologics License Application (BLA) submission, the Company proposed a number of risk management measures in line with the 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.

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 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 AR 101.