Public health agency the US Food and Drug Administration on Friday announced the approval of Palforzia to mitigate the allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanuts in individuals aged four to 17 years.

The US FDA granted approval of Palforzia [Peanut (Arachis hypogaea) Allergen Powder-dnfp] to Aimmune Therapeutics.

Peanut allergy is a condition in which the body's immune system mistakenly identifies even small amounts of peanut as harmful. Physical symptoms can develop within seconds of exposure and may include skin reactions, digestive discomfort or more dangerous reactions.

According to the agency, Palforzia is a powder that is manufactured from peanuts and packaged in pull-apart color-coded capsules for Dose Escalation and Up-Dosing and in a sachet for maintenance treatment. The powder is emptied from the capsules or sachet and mixed with a small amount of semisolid food, including applesauce, yogurt, or pudding, that the patient then consumes.

Concurrently, the effectiveness of Palforzia is supported by the company's randomized, double-blind, placebo-controlled study conducted in the US, Canada and Europe in approximately 500 peanut-allergic individuals. The results showed that 67.2% of Palforzia recipients tolerated a 600 mg dose of peanut protein in the challenge, compared to 4.0% of placebo recipients.

In conjunction, Palforzia will only be available through certified healthcare providers, health care settings and pharmacies to patients enrolled under the REMS (Risk Evaluation and Mitigation Strategy) programme to mitigate the risk of anaphylaxis associated with the product.