Statement by Sung Poblete, RN, PhD, CEO of FARE, regarding FDA’s Extended PDUFA Target Action Date for neffy® (Intranasal (IN) Epinephrine) for Allergic Reactions

“FARE (Food Allergy Research & Education) acknowledges the U.S. Food and Drug Administration's (FDA) decision to extend the Prescription Drug User Fee Act (PDUFA) target action date for the New Drug Application (NDA) of neffy® (Intranasal (IN) Epinephrine) by three months to September 19, 2023. This delay affects its potential approval and availability for the treatment of allergic reactions, including anaphylaxis, in adults and children >66 pounds.

“We understand the importance of patient access to safe and effective treatment options for allergic reactions, especially life-threatening anaphylaxis and recognize FDA’s efforts to ensure thorough evaluation and review of the NDA for neffy®, considering the potential for this needle-free option to positively impact the lives of individuals with food allergies. We must have a needle-free option to meet the needs of those in our community who have a fear of using needles.

“While the extension of the PDUFA target action date may bring disappointment and frustration to the food allergy community, specifically the over 33 million Americans with life threatening food allergies, it is essential to remember that patient safety and the rigorous evaluation of new medications are of paramount importance. The FDA's commitment to conducting a comprehensive review of neffy® is a testament to their dedication to upholding the highest standards of drug safety and efficacy.

“We encourage individuals and families affected by food allergies to remain informed, stay connected to their healthcare providers, and continue to follow the prescribed management plans for allergic reactions, including carrying and utilizing currently approved epinephrine auto-injectors as recommended by their healthcare professionals.

“We remain optimistic that the extended review period for neffy® will lead to approval of a needle-free option to treat anaphylaxis with reduced anxiety and less hesitation. We stand with the food allergy community while eagerly anticipating the FDA's decision in September, and its potential to expand treatment options for individuals with food allergies, providing them with additional choices to manage and mitigate the risks associated with allergic reactions.”