WASHINGTON, D.C. — The Food and Drug Administration (FDA) has approved an expansion for the use of Palforzia, a treatment designed to mitigate allergic reactions in children with peanut allergies. This approval now includes children aged 1 through 3 years old.
Palforzia, known scientifically as Peanut (Arachis hypogaea) Allergen Powder-dnfp, was initially approved in January 2020 for children aged 4 through 17. It helps reduce the risk of allergic reactions, including severe anaphylaxis, from accidental exposure to peanuts.
This expanded approval allows for the initiation of treatment, up-dosing, and maintenance for younger children with a confirmed peanut allergy diagnosis. However, those taking Palforzia must continue to avoid peanuts in their diets to prevent allergic reactions.
A Risk Evaluation and Mitigation Strategy (REMS) is in place to ensure the safe use of Palforzia, given the risk of anaphylaxis associated with the treatment. This strategy includes specific elements designed to mitigate these risks.
The FDA’s decision aims to provide a safety net for families of young children managing peanut allergies, enabling them to reduce the risk of life-threatening reactions through a supervised treatment plan.
This expanded use of Palforzia marks a significant step in the ongoing effort to manage and mitigate the risks associated with peanut allergies in children. The FDA continues to monitor the safety and efficacy of allergy treatments to ensure public health and safety.
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