Aimmune Therapeutics has secured approval for Palforzia [Peanut (Arachis hypogaea) Allergen Powder-dnfp] from the US Food and Drug Administration (FDA) to treat patients with peanut allergy.
Palforzia, which was formerly known as AR101, has been indicated in the US for the mitigation of anaphylaxis and other allergic reactions following accidental exposure to peanut.
The oral immunotherapy, which is derived from peanuts, is approved by the FDA for the treatment of patients having a confirmed diagnosis of peanut allergy.
Initial dose escalation may be given to patients aged four years through 17 years. Up-dosing and maintenance can be continued in patients four years of age and older, as per the FDA approval.
The drug has to be taken in conjunction with a peanut-avoidant diet.
However, the oral immunotherapy does not have approval for the emergency treatment of anaphylaxis and other allergic reactions.
FDA Center for Biologics Evaluation and Research director Peter Marks said: “Peanut allergy affects approximately 1 million children in the U.S. and only 1 out of 5 of these children will outgrow their allergy. Because there is no cure, allergic individuals must strictly avoid exposure to prevent severe and potentially life-threatening reactions.
“Even with strict avoidance, inadvertent exposures can and do occur. When used in conjunction with peanut avoidance, Palforzia provides an FDA-approved treatment option to help reduce the risk of these allergic reactions in children with peanut allergy.”
Palforzia’s biologics license application (BLA) contained efficacy and safety data recorded from seven clinical studies, which included phase 3 PALISADE and RAMSES clinical trials.
The drug’s effectiveness is backed by a placebo-controlled trial in nearly 500 peanut-allergic individuals. The trial saw 67.2% of individuals who had Palforzia, tolerated a 600mg dose of peanut protein, compared to 4% in the placebo arm.
Aimmune Therapeutics chief medical officer Daniel Adelman said: “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.”