From FDA Landmark to Market Exit: The Complex Journey of Palforzia

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In an unexpected turn for the food allergy community, Stallergenes Greer has announced the voluntary discontinuation of the commercialization of Palforzia. The decision marks a significant shift in the treatment landscape for peanut allergy, as Palforzia was the first and only FDA-approved oral immunotherapy (OIT) designed to mitigate severe allergic reactions, including anaphylaxis, following accidental exposure. The company has confirmed that the global cessation of the product will take effect on July 31, 2026.

This development follows a complex corporate journey for the medication. Originally developed by Aimmune Therapeutics, Palforzia gained historic FDA approval in early 2020 for patients aged 4 to 17. Following a multi-billion dollar acquisition by Nestlé Health Science, the drug struggled with market adoption due to the pandemic and the intensive clinical requirements of the Risk Evaluation and Mitigation Strategy (REMS) program. In late 2023, Stallergenes Greer acquired the rights to the therapy, even expanding its indication to include toddlers (ages 1–3) in 2024, before ultimately reaching this decision to exit the market.

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Crucially, Stallergenes Greer has emphasized that this voluntary discontinuation is not related to product safety, quality, or efficacy. Clinical trials, including the landmark POSEIDON study, consistently demonstrated that Palforzia was effective at increasing the threshold of peanut tolerance in allergic individuals. Instead, the move appears to be based on strategic and operational considerations within the company’s broader allergen immunotherapy portfolio, rather than any newly discovered medical risks.

To ensure the wellbeing of those currently on the therapy, Stallergenes Greer has pledged to meet all regulatory obligations throughout the wind-down period. The company aims to support an orderly transition for patients, acknowledging the specialized nature of OIT which requires precise dosing and medical supervision. Healthcare professionals are being encouraged to take this timeline into account when managing existing patients and to refrain from initiating new treatment cycles that cannot be completed before the cutoff.

For families currently utilizing the therapy, the transition period provides a window to consult with their allergists to determine the best path forward. While the discontinuation of a licensed product is a setback, many clinicians may look toward “real-food” immunotherapy or alternative emerging treatments as potential substitutes. Stallergenes Greer remains committed to patient safety and supporting healthcare providers through the final stages of the product’s availability.

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Support services will remain active during this transition to assist both providers and families. The Palforzia Pathway Patient Hub will continue to provide guidance and can be reached at 1-844-PALFORZ. Patients and caregivers who have questions regarding their specific treatment plan or the availability of remaining stock for “up-dosing” are urged to contact their physicians as soon as possible to ensure their desensitization progress is not abruptly interrupted.

As the July 2026 deadline approaches, the allergy community is left to reflect on the legacy of the first standardized peanut OIT. While Palforzia’s commercial chapter is coming to a close, the research and clinical infrastructure it helped build have paved the way for a deeper understanding of food allergy desensitization. For now, the focus remains on a safe and professional wind-down to protect the progress made by thousands of peanut-allergic children and their families.

Source: Palforzia — Company Website
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Dave Bloom
Dave Bloom
Dave Bloom is CEO and "Blogger in Chief" of SnackSafely.com.

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