The U. S. Food and Drug Administration (FDA) has approved the peanut oral immunotherapy for treating peanut allergy in toddlers aged 1-3 years in July 2024. It is expected to launch in early 2025. This approval expands the 2020 FDA approval for children aged 4-17 years. This treatment aims to gradually desensitize children to peanuts, reducing the risk of severe allergic reactions (anaphylaxis) from accidental exposure to peanuts.
The FDA approval in this aged group is based on data from the phase 3 POSEIDON (Peanut Oral Immunotherapy Study of Early Intervention for Desensitization) study in North America and Europe. The study evaluated the efficacy and safety of peanut oral immunotherapy in children aged 1 to 3 years old.
The study included 146 toddlers with a documented clinical history of peanut allergy, positive skin prick tests and/or elevated blood levels of peanut antibodies, and dose-limiting symptoms after consuming single dose of peanut protein ranging from <3 to ≤300 mg in an oral food challenge. Participants underwent a dose-escalation period of about 22 weeks to reach a daily dose of 300 mg of peanut protein powder (equivalent to one peanut or 1/4 teaspoon of peanut butter) (n=98) or placebo (n=48). They then continued that dose as the maintenance dose for about six months. At the end of the study, patients underwent an oral food challenge.
The study results showed that 68.4% of the peanut protein-treated group tolerated at least 1,000 mg of peanut protein compared with 4.2% in the placebo group. 92.9% in the peanut protein-treated group and 93.8% in the placebo group experienced adverse events that were mild or moderate in severity.
Therefore, it is an important step forward in the management of peanut allergy, especially for young children, because children's immune systems are usually most amenable to changes before the age of four. But the FDA approval does not indicate that this treatment is a cure for peanut allergy. Your child must still carry two epinephrine auto-injectors and avoid eating peanuts.
