FDA Approves Palforzia® for U.S. Pediatric Peanut Allergy Treatment

Stallergenes Greer, a globally recognized healthcare company specializing in allergen immunotherapy, has announced that the U.S. Food and Drug Administration (FDA) has approved Palforzia for treating toddlers aged 1 to 3 years with confirmed peanut allergies. This recent approval extends the FDA's January 2020 authorization that allowed the treatment for patients aged 4 to 17. Palforzia is the first and only FDA-approved oral immunotherapy (OIT) for reducing allergic reactions, including anaphylaxis, due to accidental peanut exposure.

Peanut allergy affects about 2% of the Western population and has seen a doubling in prevalence among children from 2005 to 2015. This allergy is known for its high rates of accidental exposure, severe reactions, and potential for causing fatal anaphylaxis. The combination of difficulty in avoiding peanuts and the severity of reactions underscores a significant need for effective treatment options.

Elena Rizova, MD, PhD, and Chief Medical Officer of Stallergenes Greer expressed delight over the regulatory approval for toddlers. She noted that this age group has a high unmet medical need, and the new indication is expected to alleviate the burden of peanut allergy on younger patients and their families.

The FDA's approval for toddlers is based on data from the Phase 3 POSEIDON study, which was published in the New England Journal of Medicine Evidence in 2023. This study assessed the efficacy and safety of Palforzia in peanut-allergic children aged 1 to 3 years. The study met all its primary and secondary efficacy endpoints and demonstrated a favorable safety profile.

Stallergenes Greer acquired the rights to Palforzia in September 2023. The company is committed to delivering innovative solutions in allergen immunotherapy and has focused on establishing a specialized Food Allergy business unit in the U.S. while integrating Palforzia into its AIT portfolio.

Palforzia is an oral immunotherapy treatment in the U.S. indicated for reducing allergic reactions, including anaphylaxis, that can occur with accidental peanut exposure. The treatment is approved for patients with a confirmed peanut allergy and is to be used alongside a peanut-avoidant diet. It is not indicated for emergency treatment of allergic reactions, including anaphylaxis.

Palforzia has received approval from the FDA for patients aged 1 to 17 years. It is also approved by the European Medicine Agency (EMA) for ages 4 to 17 years, by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, and by Swissmedic in Switzerland. Pediatric indication extension submissions are currently under review by both the EMA and Swissmedic.

The POSEIDON study, a Phase 3 clinical trial, was conducted internationally and involved randomized, double-blind, placebo-controlled methods to evaluate the efficacy and safety of Palforzia in peanut-allergic children aged 1 to 3 years in North America and Europe. The study was completed by Aimmune Therapeutics, part of Nestlé Health Science, before Nestlé divested Palforzia to Stallergenes Greer in September 2023.

The study included several entry criteria, such as a documented history of peanut allergy, positive skin prick tests, elevated blood levels of peanut antibodies, and dose-limiting symptoms after consuming specific amounts of peanut protein. The trial involved a dose-escalation period lasting approximately 22 weeks to reach a daily dose of 300 mg of Palforzia or placebo, followed by maintenance of that dose for an additional six months. At the trial's conclusion, patients underwent an exit double-blind, placebo-controlled food challenge (DBPCFC).

Stallergenes Greer International AG, headquartered in Baar, Switzerland, is dedicated to diagnosing and treating respiratory, food, and venom allergies through its allergen immunotherapy products and services. The company operates globally and includes subsidiaries like Greer Laboratories, Inc. in the United States and Stallergenes SAS in France.

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