The approval of the nasal spray is intended for individuals weighing more than 15 kilograms. Credit: Ground Picture/Shutterstock.com.
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has granted approval for ARS Pharmaceuticals’ epinephrine nasal spray, neffy, in both 1mg and 2mg doses for the emergency treatment of severe allergic reactions, known as anaphylaxis.
The approval is intended for individuals weighing more than 15kg, encompassing both adults and children.
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The company signed an exclusive licensing deal with Alfresa Holdings, a Japanese pharmaceutical entity, in 2020, granting the latter rights to market neffy within the country.
According to the agreement, ARS Pharma is set to receive a $2m regulatory milestone payment once neffy is listed on the Japanese National Health Institute (NHI) Drug Price List.
Additionally, the company will supply neffy to Alfresa at a predetermined transfer price. The expectation is that the spray will be introduced to the Japanese market in the last quarter of this year.
ARS Pharma CEO, president and co-founder Richard Lowenthal said: “We are proud to receive this approval in partnership with Alfresa, which broadens access to 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. With its compact design, and extended shelf life, compared to other forms of epinephrine, of 24 months, this advancement empowers patients and caregivers to consistently carry and administer epinephrine at the earliest signs of a severe reaction.”
In the US, neffy is already available for the same emergency use in adults and children aged four years and above, with a minimum weight requirement of 15kg.
This year, ARS Pharma’s European collaborator, ALK, launched EURneffy in Germany and received UK approval.
Further regulatory approvals are anticipated in several other regions.
The company expects to receive clearance for neffy in Canada through ALK, as well as in Australia and New Zealand in partnership with CSL, by the close of 2025. The subsequent commercial release is planned for the early months of 2026.
Moreover, ARS Pharma is looking forward to obtaining regulatory consent for neffy in China, in collaboration with Pediatrix, with expectations set for the first half of 2026.
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AloJapan.com