FDA Approves Aimmune’s PALFORZIA™ as First Treatment for Peanut Allergy

More than 2 million Children and Adults in the Canada & U.S. are Allergic to Peanuts

Aimmune Therapeutics, Inc, is a biopharmaceutical company  that develops and commercializes treatments for potentially life-threatening food allergies. 

On January 31st 2020, the company announced that the U.S. Food and Drug Administration (FDA) had approved PALFORZIA™, 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 peanuts. PALFORZIA is approved for use in patients with a confirmed diagnosis of peanut allergy. Initial dose escalation may be administered to patients aged 4 through 17 years. 

It is important to note that PALFORZIA is to be used in conjunction with a peanut-avoidant diet, and is NOT meant for the emergency treatment of allergic reactions, including anaphylaxis.

“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,”

Jayson Dallas, M.D., President and CEO of Aimmune Therapeutics

A peanut allergy is one of the most common food allergies in the world, affecting more than 2 million children and adults in Canada and the United States. 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,” said 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.”

Aimmune Therapeutics was founded directly in response to a united call to action by leading stakeholders in food allergy. At an advocacy-sponsored research retreat in 2011 aimed at reaching consensus on the direction of food allergy treatment research, a group of parents of children with severe food allergies, patient advocacy organizations, leading clinical and academic physicians, representatives from government, and members of the pharmaceutical industry recognized the need for a structured approach to OIT and approved treatments. This meeting eventually led to the formation of Aimmune Therapeutics to specifically address that need.

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