Palforzia, the first and only oral immunotherapy the Food and Drug Administration ever approved for peanut allergy, left the market on July 31. The manufacturer's notice from Stallergenes Greer states that the voluntary discontinuation is not related to product safety, quality or efficacy.
The product treated confirmed peanut allergy in children ages 1 through 17. Under FDA labeling, it was indicated to reduce the severity of allergic reactions, including anaphylaxis, following accidental exposure, and was to be used alongside a peanut-avoidant diet. It was never a cure, nor was it for treating a reaction in progress. The restricted access program that governed its use, a Risk Evaluation and Mitigation Strategy, is being wound down along with the product.
