FDA to hear evidence, patient perspective on breakthrough peanut allergy therapy
On Friday, September 13, the Food and Drug Administration (FDA) will hold an advisory committee meeting to review and make recommendations on the safety and effectiveness of Aimmune Therapeutics’ groundbreaking peanut allergy treatment, AR101. The committee meeting will feature the stories of clinical trial participants, families and patients living with peanut allergy and the insights of researchers and advocates. If the committee recommends the safety and efficacy of AR101, a final ruling by the FDA could make the therapy the first FDA-approved treatment for food allergies, making this a pivotal hearing not only for families managing life-threatening peanut allergy, but for the advancement of food allergy research.
Our mission at FARE is to improve the quality of life and health of individuals with food allergies, and to provide them hope through the promise of new treatments. Supporting the research and development that goes into making a product like AR101 widely available to patients is a critical component of that mission and something we are deeply committed to.
From the beginning, FARE and its vast community of patients and advocates have supported and urged the development of revolutionary treatments like AR101 as a direct response to the unmet needs of our community. In 2011, FARE and a collection of leading scientists, regulators and advocates recognized that a standardized oral immunotherapy (OIT) product and protocol had the best chance of all food allergy treatments at gaining FDA approval. As a result of this determination, Aimmune was born. FDA approval of AR101 would be a tremendous step forward for the food allergy community, potentially providing a roadmap for how future food allergy treatments are developed
FARE’s CEO, Lisa Gable, has been given the opportunity to speak on behalf of the community during the committee meeting. She will highlight the unacceptable standard of care—strict avoidance of allergens or the administration of epinephrine followed by a visit to the emergency room in the event of accidental exposure—for individuals living with a life-threatening peanut allergy today and emphasize the importance of giving patients a choice when it comes to selecting preferred treatment options.
FARE remains fiercely committed to supporting therapies with the potential to reduce the daily burden of living with any form of food allergy. Now is the time to take actionable steps toward a solution for patients living with a potentially life-threatening peanut allergy.
You can tune into a live webcast of the committee hearing at: https://collaboration.fda.gov/apac091319/