BRISBANE, Calif.—Aimmune Therapeutics, Inc., a biopharmaceutical company developing and commercializing treatments for potentially life-threatening food allergies, has announced that the U.S. Food and Drug Administration (FDA) has approved the company’s Palforzia (Peanut [Arachis hypogaea] Allergen Powder-dnfp).
Palforzia is the first approved treatment for patients with peanut allergy. It is an oral immunotherapy indicated for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. Palforzia is approved for use in patients with a confirmed peanut allergy diagnosis. Initial dose escalation may be administered to patients aged 4 through 17 years. Up-dosing and maintenance may be continued in patients 4 years of age and older. Palforzia is intended to be used in conjunction with a peanut-avoidant diet.
“This is a defining moment for the peanut allergy community and for Aimmune Therapeutics, and we are excited to bring the first FDA-approved treatment for peanut allergy to patients and their families,” said Jayson Dallas, M.D., president and CEO of Aimmune Therapeutics. “Our commercial field team is ready to begin engaging with allergists to help them prepare to safely incorporate Palforzia into their practices and, with approval in hand, our payer team can also immediately begin work to secure formulary access to Palforzia. We view this approval as just the beginning for Aimmune, and it underscores our continued commitment to bringing innovative treatments to people with potentially life-threatening food allergies.”
“Not only is Palforzia the first approved therapy for peanut allergy, but it is the first approved therapy for any food allergy. We truly appreciate the efforts of the peanut allergy community who contributed to the development of Palforzia — including the more than 1,200 patients and their families who participated in our clinical trials, the study investigators and their staff, the advocacy community, and our dedicated employees — all of whom have helped us develop and deliver this first-of-its kind therapy,” noted Daniel Adelman, M.D., chief medical officer of Aimmune Therapeutics.
Peanut allergy is a very common food allergy that affects more than 1.6 million children and teens in the U.S. alone. It can be a chronic and life-long condition, and reactions to peanut can range from mild to potentially life-threatening, with one in five peanut-allergic patients visiting emergency rooms each year due to accidental exposures.
“Peanut allergy is more common now than ever before and has become a serious public health concern. The food allergy community has been eagerly awaiting an FDA-approved treatment that can help mitigate allergic reactions to peanut and, as allergists, we want nothing more than to have a treatment option to offer our patients that has demonstrated both the safety and efficacy to truly impact the lives of patients who live with peanut allergy,” added Christina Ciaccio, M.D., associate professor of Pediatrics and Medicine and chief of Allergy/Immunology and Pediatric Pulmonary Medicine at the University of Chicago Medical Center and Biological Sciences. “With today’s approval of Palforzia, we can – for the first time – offer children and teens with peanut allergy a proven medicine that employs an established therapeutic approach.”
Palforzia is a biologic drug used with a structured dosing approach that builds on a century of oral immunotherapy (OIT) research. With OIT, the specific allergenic proteins are initially ingested in very small quantities, followed by incrementally increasing amounts. This results in the ability to mitigate allergic reactions to the allergen over time. Palforzia is a pharmaceutical-grade OIT for peanut allergy with a well-defined allergen profile to assure that every dose, whether 0.5 mg (equivalent to 1/600th of a peanut) or 300 mg, has been prepared and analyzed for consistency.
The biologics license application (BLA) for Palforzia included efficacy and safety data from seven clinical studies, including the pivotal Phase 3 PALISADE and RAMSES clinical trials. In addition, data from the Phase 2 ARC001 study and the ARC002 open-label follow-on study were included, as well as data from ARC004, ARC008 and ARC011, which are ongoing studies.
Palforzia is only available through a Risk Evaluation and Mitigation Strategy (REMS). Requirements of the REMS include: the prescribing physician and patient must be enrolled in the REMS prior to initiation of treatment; the initial dose escalation and the first dose of each up-dosing level must be administered in a certified healthcare setting; epinephrine must always be immediately available to patients; and pharmacies/distributors must be certified with the REMS and dispense Palforzia only to certified healthcare settings or to patients who are enrolled in the REMS.
Aimmune plans to provide resources to patients and families who, upon consultation with their physician, wish to seek treatment with Palforzia. These resources will include educational materials, a dedicated call center, a co-pay program for eligible patients and a patient assistance program to provide Palforzia at no cost to eligible patients.
“Peanut allergy carries an overwhelming psychosocial burden that impacts patients and their families daily — peanuts are everywhere, and the threat of a severe reaction related to an accidental peanut exposure dominates families’ daily lives. The risk of accidental exposure is real, and we, as a community, have long awaited an option beyond avoiding peanuts alone. As one of the organizations that originally highlighted the need for an FDA-approved oral treatment approach to food allergy back in 2011, we are thrilled with today’s FDA approval of Palforzia as it fills a long-standing need in the treatment of peanut allergy,” concluded Lisa Gable, chief executive officer, Food Allergy Research and Education (FARE).