FDA-Approved Peanut Allergy Immunotherapy Exits Market

The only FDA-approved oral immunotherapy (OIT) product, known as peanut allergy treatment Palforzia, is exiting the market. The standardized peanut protein product was originally approved for treating peanut allergy in children between the ages of 4 and 17 in 2020, but it was discontinued in July. The company behind the product, Stallergenes Greer, cited low uptake as the reason for discontinuation.

Allergist-immunologist David M. Fleischer, MD, from the University of Colorado Anschutz, told MedPage Today that he doubts it was ever a viable model for success. Palforzia's discontinuation is unlikely to impact daily practices, as allergists already have comfortable alternatives for OIT. The standardized product provided less variability in peanut protein content, which could be crucial for safety during the early stages of OIT.

However, the non-negligible risk of anaphylaxis and the administrative burden of participating in Palforzia's Risk Evaluation and Mitigation Strategy (REMS) Program made it less attractive. Other allergens, such as eggs, sesame, and tree nuts, also have off-the-shelf products for OIT, making Palforzia's discontinuation less of a blow.

The Allergy and Asthma Network notes that insurance might not cover treatments without FDA approval. Looking ahead, there are hopes for innovation, with a peanut epicutaneous immunotherapy patch expected to be reviewed by the FDA before the end of the year, and other potential treatments, such as oral nanoparticle vaccines and neutralizing antibodies, in the pipeline.