ARS Pharmaceuticals has launched Neffy epinephrine nasal spray in the US, the company said. In Auguest 2024, Neffy was approved by the FDA for the treatment of anaphylaxis in patients who weigh 30 kg or more. Earlier this month, ARS submitted an sNDA for a lower dose of Neffy for the treatment of anaphylaxis in children weighing 15 to 30 kg (33-66 lbs).
European regulators approved the European version of the product, EURneffy adrenaline nasal spray, a few days after the US approval. In its announcement of the US launch, ARS says that it expects a partner based in the EU to launch EURneffy “in certain EU Member States” by the end of this year.
Separately, CDMO Renaissance Lakewood announced that it is manufacturing Neffy and reported the addition of two new packaging lines to handle the additional volume as part of an ongoing expansion. Renaissance noted that it has been partnered with ARS on development of Neffy for 6 years, including formulation optimization and clinical trial supplies.
ARS Pharmaceuticals Chief Commercial Officer Eric Karas commented, “The introduction of Neffy as the first and only needle-free treatment option for patients and caregivers living with severe allergic reactions marks a turning point for ARS Pharmaceuticals and the severe allergy community. Since approval, we have been partnering with healthcare providers, payers, and patient advocates to ensure access for patients. Pharmacies are processing prescriptions, our supply chain is fully operational, and most importantly, the first patients are now receiving Neffy.”
ARS President and CEO Richard Lowenthal said, “Years of dedication from the entire allergy community and healthcare providers have paved the way for Neffy as the first needle-free epinephrine treatment for severe allergies. We are so proud of our team members who have worked diligently from conception through FDA approval to make Neffy available. Now that people can begin using Neffy, we are looking forward to seeing how it positively impacts up to 40 million people in the US who experience severe allergic reactions.”
Read the ARS Pharmaceuticals press release.
Read the Renaissance Lakewood press release.
