FDA Advisory Committees - FDA Center for Biologics Evaluation and Research (CBER) - Allergenic Products Advisory Committee (APAC)
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.
The Committee heard updates of research programs in the Laboratory of Immunobiochemistry of the Division of Bacterial, Parasitic and Allergenic Products (DBPAP), Office of Vaccines Research and Review (OVRR), Center for Biologics Evaluation and Research (CBER), FDA. The open session portion of the meeting occurred by teleconference from 1:00 PM – 2:20 U.S. EDT.
The Committee will discuss safety and effectiveness data, including challenge study endpoints, for licensure of food allergy immunotherapy products, and the clinical development of aeroallergen immunotherapy products for the prevention of respiratory allergic disease.
Allergenic Products Advisory Committee (APAC)
APAC reviews and evaluates available data concerning the safety, effectiveness, and adequacy of labeling of marketed and investigational allergenic biological products or materials that are administered to humans for the diagnosis, prevention, or treatment of allergies and allergic disease, and makes appropriate recommendations to the Commissioner of Food and Drugs of its findings.