The committee met to discuss and make recommendations on the safety and efficacy of AR101, Peanut [Arachis hypogaea] Allergen Powder, manufactured by Aimmune Therapeutics, Inc. (Aimmune), proposed to reduce the incidence and severity of allergic reactions, including anaphylaxis, after accidental exposure to peanuts in patients aged 4 to 17 years with a confirmed diagnosis of peanut allergy. The proposed trade name is Palforzia. The product consists of a peanut allergen powder that has been evaluated for standardized quantities of specific allergenic peanut proteins.
A majority of the committee, seven of nine committee members, voted that the available efficacy data are adequate to support the proposed use.
Regarding safety, a majority of the committee, eight of nine committee members, voted the available safety data, in conjunction with additional safeguards under a Risk Evaluation and Mitigations Strategies (REMS) program, are adequate to support the proposed use.