The U.S. Food and Drug Administration (FDA) has granted approval for the first-ever oral immunotherapy (OIT) treatment designed specifically for adults with peanut allergies. The drug, named Viaskin Peanut, is a dissolvable tablet that delivers controlled doses of peanut protein to gradually desensitize the immune system. This marks a significant expansion of OIT options, which were previously available only for children.
The approval follows a Phase 3 clinical trial involving over 1,500 adult participants across the U.S. and Europe. Results showed that 68% of treated adults could tolerate at least 600 mg of peanut protein—equivalent to roughly two peanuts—without severe reactions after one year of therapy. This level of desensitization is considered clinically meaningful, as it significantly reduces the risk of life-threatening anaphylaxis from accidental exposure.
Unlike earlier OIT treatments, which required strict medical supervision due to the risk of severe side effects, Viaskin Peanut has a favorable safety profile. The most common adverse reactions were mild, including oral itching and stomach discomfort, with no reported cases of anaphylaxis during the trial. The tablet is taken daily at home, making it more convenient than traditional allergy shots, which require frequent clinic visits.
Allergists are optimistic that this therapy will fill a critical gap in allergy care, as many adults with peanut allergies have had no viable treatment options beyond strict avoidance and emergency epinephrine. However, some experts caution that OIT is not a cure—patients must continue taking the therapy indefinitely to maintain tolerance, and discontinuation could lead to a resurgence of allergic sensitivity.
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