Palforzia Discontinuation Ends Only FDA-Approved Peanut OIT

Palforzia (peanut allergen powder-dnfp), the first and only FDA-approved oral immunotherapy for peanut allergy, was officially discontinued on July 31, 2026, a timeline the manufacturer has attributed to commercial rather than safety, quality, or efficacy factors.¹

Robert Wood, MD, of Johns Hopkins University, who studies oral immunotherapy (OIT) outcomes in food-allergic children, said Palforzia's launch coincided with the onset of the COVID-19 pandemic, which paused in-office dose escalations for roughly a year. Prescribing requirements slowed adoption further, and clinicians increasingly turned to non-FDA-regulated peanut products for OIT once maintenance protocols proved workable outside the Palforzia framework.

“The reality is the practice of OIT has continued, and very few people out there will be missing Palforzia as a treatment option, because those who want to do peanut OIT will continue to do it with products purchased over the counter in the grocery store,” Wood said.

For patients already at a maintenance dose, Wood said transitioning off Palforzia carries limited risk, since standardized maintenance amounts, such as a fixed daily peanut-protein serving, are easier to trust from a grocery-store source than the microgram-level doses used at initiation. Risk calculus shifts most for patients still early in dose escalation, when product potency and labeling accuracy matter more.

Omalizumab and Multi-Allergen Care

With Palforzia off the market, omalizumab (Xolair) stands as the only FDA-approved food allergy therapy available. Wood said treatment selection now hinges heavily on how many foods a patient reacts to, since multi-allergen OIT carries a higher side-effect burden than single-food OIT.

At Johns Hopkins, Wood’s team increasingly pairs omalizumab with staged food introduction, using the biologic as daily protection while patients incorporate allergens such as milk or wheat, sometimes discontinuing omalizumab later if food tolerance holds. Wood said the decision remains family-specific, weighing the number of allergens, desired dietary goals, and tolerance for risk.

Full discussion of these treatment-sequencing questions, including perspective from Jacqueline Ross, MD, is available in HCPLive's companion video feature on the Palforzia discontinuation.

Editor’s note: Reported disclosures for Wood include Genentech and Novartis Pharmaceuticals Corporation.

References

1. Palforzia Discontinued: Ending the Only FDA-Approved Peanut OIT. HCPLive. https://www.hcplive.com/view/palforzia-discontinued-ending-only-fda-approved-peanut-oit. Published July 31, 2026. Accessed August 6, 2026.

2. With Palforzia® Ending, What’s Next for Peanut Allergy Patients? Allergy & Asthma Network. Palforzia discontinued. August 3, 2026. Accessed August 6, 2026. https://allergyasthmanetwork.org/news/palforzia-discontinued/.