FDA approves NEFFY for anaphylaxis in 4 years old and old modified | Image credit: © Calin- © Calin -STOCK.ADOBE.COM.
According to ARS Pharmaceuticals, on March 5, 2025, 1 mg of Epinephrine Cosuticals (NEFFY) was approved to treat the I -type allergic reactions, including anaphylaxis, in children over 4 to 66 pounds.1
With approval, neffy is the first and only needle -free epinephrine treatment. Since August 9, 2024, signs of younger populations occur, resulting in initial approval of NEFFY for adults and pediatric patients over 66 pounds.1,2
NEFFY 1 mg is expected to be provided in the United States by the end of May 2025, and ARS mentioned in the presentation.1
David Fleischer, the manager of Allergy & Immunology, said, “The possibility of using an epinephrine option without needles for children is a breakthrough in the treatment of serious allergic reactions.”1
“Many people are waiting for Epinephrine to be administered or antihistamines until the symptoms progress, so they are waiting for the first defense. Neffy’s small and user -friendly design solves this challenge to actually carry Epinephrine and act quickly and confidently while allergies. Innovation will improve your health, increase your life, and improve your life. ”
According to ARS, the approval of 1 mg of NEFFY is based on pharmacological and biological reactions in both pediatric and adult patients who match the epinephrine injection products. ARS pointed out that children under 10 years of age can effectively use neffy based on human factor studies.
NEFFY for resistance to the storage life of 24 months at room temperature and up to 122 ° F (50 ° C) for up to 3 months offers more effective benefits than EPIPENS. Modern pediatrics Board of Directors, Russell Libby, MD, FAAP.1,3
“When you see epipens, you have a really narrow temperature that keeps it stably. What does that mean? Well, sometimes it can be meaningless, but it can be reduced more often.” Modern pediatrics It was posted after NEFFY was originally approved.3
Libby said, “We can get 90% or 70%. We do not think there are many data about it, but basically we know that it is very specific to be stored within 60 ~ 90 degrees of room temperature.
The approval of NEFFY 1 mg has been announced for nearly two months that ARS has been submitted in a financial report for a young label with the FDA. NEFFY approved the prescription drug user fees on March 6, 2025.1
ARS’s president and CEO, Richard Lowentshal, said, “Today’s FDA approval for NEFFY 1 mg is a major milestone in trying to change the management of serious allergic reactions.
“Many children and caregivers are afraid of a needle -based automatic syringe and can save life. Neffy’s no needle and easy -to -use design solves this unhearded needs to provide an alternative to the family for a long time. “Nearly 4 of the 10 US Epinephrine prescriptions written for children under 18 years old, almost 1/3 of children with weight of 15 to 30 kilograms.4 We believe that 1 mg of NEFFY will improve access to options without needles for serious allergic treatment and reduce hesitation in treating these vulnerable groups. It will also remove the danger of accidental needle injuries to children and caregivers. ”
To place NEFFY on the shelves of various school nurses in the United States, eligible schools can receive NEFFY through the NEFFYINSCHOOLS program of ARS, which was released in January 2025.4
Further Read: ARS starts a program to provide free NEFFY at eligible K-12 schools.
reference:
ARS Pharmaceuticals announced the FDA approval of NEFFY® 1 MG (Epineprine Cotor Spray) for an I -type allergic reaction including anaphylactic in a 15 to 30 kilogram pediatric patients. ARS Pharmaceuticals. March 5, 2025. Approach March 6, 2025.
2. Fitch and J. FDA approve NEFFY as the first cospray to treat anaphylaxis. Modern pediatrics. August 9, 2024. Approach March 6, 2025.
3. Neffy, Russell Libby, MD, FAAP. Modern pediatrics. January 1, 2025. Approach March 6, 2025.
4. Fitch and J. ARS start a program to provide free NEFFY at the eligible K-12 school. Modern pediatrics. January 22, 2025. Approach March 6, 2025.
