Neffy 1 mg is the “first significant innovation” for epinephrine delivery in small children aged 4 years and up in over 35 years, according to ARS Pharmaceuticals.
The FDA gave the go-ahead to a 1-mg formulation of ARS Pharmaceuticals’ epinephrine nasal spray neffy, allowing its use to treat type I allergic reactions, including anaphylaxis, in small children.
Specifically, a 1-mg dose of neffy can now be given to pediatric patients aged 4 years and older who weigh at least 15 kg but less than 30 kg. According to ARS Pharma, the nasal spray is the “first significant innovation” in administering epinephrine to children “in more than 35 years.”
Neffy was first approved in August 2024, becoming the industry’s first nasal spray to address severe allergies. ARS CEO CEO Richard Lowenthal at the time called the approval “a watershed moment” for allergy care.
The company expects neffy to be available in pharmacies by the end of May 2025 and, through a co-pay savings program, will cap out-of-pocket cost at $25 for two single-use application devices for “most commercially insured patients,” as per the company’s press announcement. Otherwise, the two doses of neffy will cost $199.
Lowenthal in a statement called Wednesday’s approval “a major milestone” not just for the company but also for children, their families and their healthcare providers. “Many children and caregivers fear needle-based auto-injectors, which can delay lifesaving treatment.”
“We believe neffy 1 mg will improve access to a needle-free option for the treatment of severe allergies and reduce hesitation in treating this vulnerable group,” Lowenthal continued.
The neffy nasal spray contains ARS Pharma’s formulation of epinephrine, mixed with the proprietary absorption agent dodecyl-maltoside, a well-established anti-allergy medication. The hormone therapeutic works by targeting both alpha- and beta-adrenergic receptors, in turn relaxing the airways and tightening the blood vessels—both of which serve to counter the common symptoms of anaphylaxis.
Elsewhere in the allergy space, Roche’s Genentech and development partner Novartis reported on Sunday that their asthma drug Xolair bested oral immunotherapy—in a trial where patients were exposed to increasing amounts of the allergen—at treating food allergies. Following Xolair treatment, 36% of patients were able to tolerate at least 2,000 mg of peanut protein taken together with two other food allergens.
This latest win for Xolair is good news for Novartis, which in January 2024 was forced to terminate a Phase III trial for ligelizumab, a subcutaneous biologic therapy that the pharma was positioning as a successor to Xolair. Novartis no longer lists the asset on its pipeline page.
