ARS Pharmaceuticals' Neffy® Filed for Approval in China, Japan, and Australia
核心洞察
ARS Pharmaceuticals' licensing partners have filed for approval of Neffy® (搜索) (epinephrine nasal spray) in China, Japan, and Australia.
A Phase 3 study in Japanese pediatric patients showed 100% responded to a single dose of Neffy® (搜索) for anaphylactic symptoms, with a median resolution time of 16 minutes.
PK/PD studies in Chinese individuals replicated U.S. trial results, supporting the efficacy and safety profile of Neffy® (搜索).
ARS Pharmaceuticals has announced that its licensing partners in China, Japan, and Australia have filed for approval of Neffy® (搜索) (epinephrine nasal spray) 2 mg in their respective countries. This follows the recent approval of Neffy® in the U.S. for the treatment of Type I allergic reactions, including anaphylaxis (搜索), in adults and children weighing ≥30 kg (66 lbs).
Expansion of Neffy® to Asia Pacific
Richard Lowenthal, Co-Founder, President and CEO of ARS Pharmaceuticals, stated, "Given the life-saving potential of Neffy® (搜索) for the emergency treatment of severe allergic reactions, our focus is on making it available as quickly and as broadly as possible worldwide." He highlighted the unique attributes of Neffy®, such as its needle-free administration, ease of disposal, compact size, temperature stability up to 122°F (50°C), and a 30-month shelf life, as particularly beneficial for the Asia Pacific region.
Clinical Trial Data
Among the clinical trials supporting these filings, a Phase 3 study in Japanese pediatric patients aged 6-17 (n=15) who developed anaphylactic symptoms after an oral food challenge (OFC) demonstrated that 100% of patients responded to a single dose of Neffy® (搜索) when dosed upon experiencing respiratory, gastrointestinal, or circulatory symptoms of grade 2 or higher, according to the Japanese Society of Allergology Anaphylaxis (搜索) Guidelines 2022. The median time to complete resolution of anaphylaxis symptoms was 16 minutes.
Pediatrix, ARS Pharma's partner in China, also conducted an 81-person PK/PD study in Chinese individuals. This study replicated the U.S. primary studies, assessing single and repeat doses administered by caregivers, self-administration, and nasal allergen challenge. The results were consistent with those obtained in the U.S. clinical trials, further supporting Neffy's efficacy and safety profile.
Global Partnerships
ARS Pharma retains all U.S. rights for Neffy® (搜索) and has licensing partnerships in China, Japan, Australia, and New Zealand with Pediatrix Therapeutics (搜索), Alfresa Pharma (搜索), and CSL Seqirus (搜索), respectively. Additionally, ARS Pharma has an exclusive agreement with ALK-Abelló to commercialize Neffy® in Europe (marketed as EUR Neffy®), Canada, and other regions outside the United States. EUR Neffy® received EU approval in August 2024.
About Neffy®
Neffy® (搜索) is an intranasal epinephrine product designed for patients with Type I allergic reactions, including those triggered by food, medications, and insect bites, which can lead to life-threatening anaphylaxis (搜索). It is indicated for emergency treatment of Type I allergic reactions, including anaphylaxis, in adult and pediatric patients weighing 30 kg or greater.