Kaleo said today that the FDA granted priority review to a supplemental new drug application for Kaleo’s Auvi-Q 0.1 milligram epinephrine auto-injector.
The privately-held pharmaceutical company touted this version of its device as the first specifically designed for the treatment of life-threatening allergic reactions in infants and small kids. The 0.1 mg auto-injector sports a shorter needle length and a lower dose of epinephrine than conventional allergy auto-injectors.
According to previous research, young children treated with a standard-sized auto-injector are at risk of having the needle strike a bone, which can affect the administration of epinephrine during an emergency, Kaleo reported.
“National Institutes of Health guidelines now recommend that certain infants be evaluated for potential peanut allergy and early peanut introduction as young as four to six months old,” Eleanor Garrow-Holding, president & CEO of the Food Allergy & Anaphylaxis Connection Team, said in prepared remarks. “We applaud the development of the first epinephrine auto-injector specifically designed to treat infants and small children who may be at risk for peanut or other life-threatening allergies. As there is currently no EAI on the market specifically designed for this precious population, we hope that the Auvi-Q 0.1 mg is approved as soon as possible.”
“Kaléo is proud to be taking a leadership role in helping to fulfill this unmet medical need that has been identified for over a decade by parents of young children and the pediatric allergy healthcare practitioner community,” president & CEO Spencer Williamson added.
“The Auvi-Q 0.1 mg auto-injector in development not only contains a dose of epinephrine tailored to infants and small children, but contains important product features such as an optimized needle length designed to help mitigate the risk of striking bone in this population,” Dr. Eric Edwards VP of innovation and R&D said.