According to ARS Pharmaceuticals, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has approved 1mg and 2mg doses of neffy epinephrine nasal spray for the treatment of anaphylaxis in people who weigh more than 15 kilograms. The company said that Alfresa Holdings, which has the rights to market neffy in Japan, expects to launch the product by the end of this year.
Neffy has been approved In the US and in Europe (as EURneffy) since August 2024. The MHRA recently approved EURneffy in the UK. ARS says that it expects neffy to be approved in Canada, Australia, and New Zealand by the end of this year and in China in the first half of next year.
ARS Pharma President and CEO Richard Lowenthal commented, “We are proud to receive this approval in partnership with Alfresa, which broadens access of neffy and offers the first needle-free epinephrine treatment available in Japan for both adults and children with severe allergies. This represents a significant breakthrough as neffy meets a vital need for patients who may not carry, or hesitate to use, an injectable option for use during emergencies.”
Read the ARS Pharmaceuticals press release
