2020-02-01| Trials & Approvals

Aimmune’s PALFORZIA™ Scores FDA Win, Becomes the First Ever Treatment For Peanut Allergy

by Rajaneesh K. Gopinath
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By Rajaneesh K. Gopinath, Ph.D.

First Treatment Ever for Peanut Allergy

California based biopharma, Aimmune Therapeutics today announced the USFDA approval of PALFORZIA™ for the treatment of children between ages 4 and 17 who suffer from peanut allergy. Jayson Dallas, the CEO termed it “a defining moment for the peanut allergy community and for Aimmune Therapeutics”.

“Not only is PALFORZIA™ the first approved therapy for peanut allergy, but it is the first approved therapy for any food allergy,” said Daniel Adelman, M.D., Chief Medical Officer of Aimmune Therapeutics in a press statement.

Peanut Allergy

Peanut allergy is a dangerous food allergy, the incidence of which has tripled between 1997 to 2008, with an estimated 1.6 million cases in the US. Even trace amounts of the allergen could cause mild reactions such as stomach aches and hives. In more severe cases, it could lead to anaphylaxis, where the swelling of the throat and low blood pressure could prove fatal, if not controlled immediately with antihistamines and epinephrine. Patients with this condition have to follow a life-long dietary restriction of peanuts. “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,” said Lisa Gable, CEO, Food Allergy Research and Education (FARE).

Treatment with PALFORZIA™

The major goal of this therapy is to protect patients from life-threatening allergic reactions (anaphylaxis) if they were to ingest peanut products accidentally. PALFORZIA™ is an oral immunotherapy drug candidate which comprises of 600 mg of peanut powder given in increasing doses. The therapy is not a cure but increases the threshold of patients to the peanut allergen. As a result, patients must still continue to avoid peanut in their regular diet. Besides, PALFORZIA™ comes with a warning that it can cause anaphylaxis, and can occur at any time during therapy. Therefore, patients who experience certain allergic reactions must stop treatment.

Strong Clinical Trial Data

The BLA of PALFORZIA™ included efficacy and safety data from 7 clinical studies that comprised of 2 phase II and 5 phase III studies. ARC003 is a phase III, randomized, double-blind, placebo-controlled, multicenter study that evaluated the efficacy and safety of PALFORZIA™ in 555 patients, in which 499 of them were between 4 and 17 years. The primary efficacy endpoint of the study was the proportion of subjects who tolerated a dose of at least 600 mg of the peanut protein without severe adverse reactions. Data shows that 67.2% of patients tolerated PALFORZIA™ as compared to only 4% in the placebo arm. Last September, its licensing was supported by the Allergenic Products Advisory Committee (APAC) panel which voted 7-2 in favor of its approval.

Reactions to the News

“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,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “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.”

Aimmune’s stocks soared 22% on Friday since the announcement.



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