ARS Pharma Files neffy® For Approval In China, Japan, And Australia

ARS Pharmaceuticals, Inc. is a biopharmaceutical company focused on empowering at-risk patients and caregivers to manage severe allergic reactions. The company has announced that its partners in China, Japan, and Australia have submitted approval applications for neffy® (epinephrine nasal spray) 2 mg in their respective regions. Recently approved in the U.S., neffy is indicated for treating Type I Allergic Reactions, including anaphylaxis, in adults and children weighing 30 kg (66 lbs) or more.

To support these submissions, ARS Pharma and its partners conducted multiple clinical studies. In Japan, a Phase 3 trial evaluated neffy in pediatric patients aged 6-17 (n=15) who experienced anaphylactic symptoms after an oral food challenge. Neffy was administered when symptoms reached grade 2 or higher, as per the Japanese Society of Allergology Anaphylaxis Guidelines 2022. The trial showed that 100% of patients responded to a single dose, with a median symptom resolution time of 16 minutes.

Richard Lowenthal, Co-Founder, President and CEO of ARS Pharmaceuticals, said, “Given the life-saving potential of neffy for the emergency treatment of severe allergic reactions, our focus is on making it available as quickly and as broadly as possible worldwide. People in the Asia Pacific region could soon be saying hello to neffy where the unique attributes of the product, such as being needle-free, easy to dispose, a smaller size with temperature excursions up to 122°F (50°C), and a 30 month shelf life are particularly important. We are thankful to our licensing partners in these countries for filing with their respective regulatory agencies.” 

In China, Pediatrix Therapeutics conducted an 81-person PK/PD study replicating the primary U.S. trials. These tests, which included single and repeat dosing, caregiver and self-administration, and nasal allergen challenges, showed favourable outcomes when compared to U.S. results.

ARS Pharma holds U.S. rights for neffy and has licensing agreements with Pediatrix Therapeutics (China), Alfresa Pharma (Japan), and CSL Seqirus (Australia/New Zealand). The company also partners with ALK-Abelló for commercialization in Europe (under the name EURneffy), Canada, and other markets, with European approval granted in August 2024.