BRISBANE, Calif.--(BUSINESS WIRE)--Sep. 13, 2019-- 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.
AR101 is an investigational biologic oral immunotherapy designed to reduce the frequency and severity of allergic reactions in case they are accidentally exposed to peanut. AR101 has been studied in clinical trials involving over 1,000 participants.
Patients ingest controlled, increasing amounts of AR101 over a period of about six months or longer. The result is that the patient’s immune system tolerates larger amount of peanut. After the dose escalation period, the patient continues to take a daily therapeutic dose to maintain desensitization.