ARS Pharmaceuticals has announced that its partners in China, Japan, and Australia have all submitted marketing applications for approval of neffy epinephrine nasal spray for the treatment of serious allergic reactions in their respective countries. ARS is partnered with Pediatrix Therapeutics in China; with Alfresa Pharma in Japan; and with CSL Seqirus in Australia and New Zealand.
In the US, neffy was approved by the FDA for the treatment of anaphylaxis in August 2024; in Europe, EURneffy adrenaline nasal spray was approved that same month. In November 2024, ARS announced that ALK-Abelló acquired the rights to market neffy everywhere except China, Japan, Australia, New Zealand, as well as in the US, where ARS retains the rights to the product.
ARS Pharmaceuticals President and CEO Richard Lowenthal commented, “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.”
Read the ARS Pharma press release.
