FDA advisory committee votes in support of favourable benefit-risk profile for ARS Pharmaceuticals’ allergic reaction treatment
James Spargo | May 12, 2023 | News story | Research and Development | ARS Pharmaceuticals, Allergic Disorders, FDA, allergy
US-based biopharmaceutical company ARS Pharmaceuticals has announced that the US Food and Drug Administration (FDA)’s Pulmonary-Allergy Drug Advisory Committee (PADAC) has voted in support of a favourable benefit-risk profile for severe allergic reaction, including anaphylaxis, treatment.
Neffy (ARS-1) is a needle-free, intranasal epinephrine product. It is indicated for use in adults and children with Type 1 allergic reactions, including food, medication and insect bites, that could lead to life-threatening anaphylaxis.
The PADAC voted 16:6 in favour for adults and 17:5 in favour for children (under 18 years old and above 30kg) based on a review of data from FDA-approved clinical studies which highlighted the safety and effectiveness of intranasal epinephrine compared to epinephrine injection.
Richard Lowenthal, co-founder, president and CEO of ARS Pharmaceuticals, commented: “We’d like to thank PADAC members for their robust scientific discussions and clinical perspectives. The Committee’s thoughtful review of the data, and support of the potential for Neffyto address significant unmet needs of the severe allergy community, if approved, is highly encouraging. We believe our clinical data from more than 600 individuals demonstrates Neffy’s absorption-enhancing nasal spray technology is comparable to injectable products in delivering potentially life-saving epinephrine, but with unique advantages of being small, needle-free and conveniently sized. We are committed to making it easier for patients and caregivers to carry and administer epinephrine without the anxiety and hesitation associated with using a needle-based device. We were moved by the outpouring of support for Neffyahead of and throughout this meeting, and we are especially grateful to those individuals who shared their personal experiences, illustrating the positive impact Neffy may create for millions of individuals and families in the future.”
James Spargo
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