Palforzia, the sole FDA-approved oral immunotherapy for peanut allergy, was discontinued on July 31, with the manufacturer, Stallergenes Greer, clarifying the decision is unrelated to safety, quality, or efficacy concerns. The treatment, designed for children aged 1–17 with confirmed peanut allergy, previously helped reduce the severity of reactions, including anaphylaxis, when paired with strict avoidance diets. Its restricted-use program is also being phased out.
Families navigating ongoing treatment schedules now face uncertainty about maintaining tolerance built over months without the standardized product. The drug, approved in 2020 and later acquired by Stallergenes Greer after a $2 billion deal involving Nestlé Health Science, struggled with complex dosing protocols and administrative hurdles. The pandemic further delayed in-office escalations, while payer resistance limited accessibility.
Dr. Robert Wood of Johns Hopkins noted that families are unlikely to feel its absence, as office-based treatments using non-FDA-approved peanut products remain viable alternatives. However, these lack standardized dosing and insurance coverage consistency.
Omalizumab (Xolair), now the only FDA-approved food allergy therapy since its 2024 approval, offers another option, particularly for multi-allergen sensitivities, though it requires careful administration. Investigational treatments like epicutaneous patches and sublingual therapies are not yet available.
The shift removes one source of uniformity, forcing families to rely on individual allergist protocols for maintenance post-discontinuation. Abrupt changes to dosing are strongly discouraged, as they risk regressing tolerance.
Families must continue strict avoidance, carry epinephrine, and maintain updated emergency plans. The discontinuation’s full impact hinges on future FDA actions or new treatments, while insurers and providers grapple with a lack of standardized references.
Key Questions Answered
When did Palforzia leave the market? Commercialization ended July 31, 2026, with phased production discontinuation.
Was it recalled for safety? No. Voluntary withdrawal cites administrative and dosing challenges, not safety or efficacy issues.
Who was it approved for? Children ages 1–17 with confirmed peanut allergy. Initially approved for ages 4–17, the range expanded later.
Should my child stop remaining doses? Consult an allergist; abrupt changes may reverse progress.
What options remain? Office-based immunotherapy with non-FDA-approved products or omalizumab.
Is the peanut patch available? No; epicutaneous and sublingual therapies remain investigational.
Can peanuts be eaten freely? No. Treatments reduce reaction severity but elimination and epinephrine access remain critical.
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