U.S. FDA approves Kaléo’s Auvi-Q (epinephrine injection, USP) 0.1 mg auto-injector for life-threatening allergic reactions in infants and small children
The U.S. Food and Drug Administration (FDA) has approved Kaléo’s supplemental New Drug Application (sNDA) for Auvi-Q (epinephrine injection, USP) 0.1 mg, the first and only epinephrine auto-injector (EAI) specifically designed for the treatment of life-threatening allergic reactions, including anaphylaxis, in infants and small children weighing 16.5 to 33 pounds (7.5 to 15 kilograms) who are at risk for or have a history of serious allergic reactions.
The sNDA for the Auvi-Q 0.1 mg auto-injector was granted Priority Review by the FDA, an expedited regulatory pathway reserved for products that may provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to available therapies.
Auvi-Q is a compact epinephrine auto-injector with industry-first features, including a voice prompt system that guides a user with step-by-step instructions through the delivery process, and a needle that automatically retracts following administration. The new 0.1 mg-dose epinephrine auto-injector has a shorter needle length and lower dose of epinephrine than current FDA approved 0.15 mg and 0.3 mg epinephrine auto-injectors.
Children are increasingly being treated for anaphylaxis. There was a 129.8 percent increase in emergency room visits for anaphylaxis among children four years old and younger between 2005 and 2014.i
According to a study published in Allergy, Asthma & Clinical Immunology, 43 percent of children weighing 16.5 pounds (7.5 kilograms) to 33 pounds (15 kilograms) treated with a 0.15 mg EAI having a standard 12.7 mm needle length are at risk of having the needle strike the bone, therefore potentially impacting the administration of epinephrine during a life-threatening emergency.ii The needle length in Auvi-Q 0.1 mg was specifically designed for use with infants and small children to help mitigate this safety concern.
Only Auvi-Q 0.1 mg has a dose and needle length designed specifically for treating anaphylaxis in infants and small children weighing 16.5 – 33 pounds. Auvi-Q 0.1 mg includes the innovative Auvi-Q electronic voice instruction system as well as visual cues to help guide users step-by-step through the administration.
The Auvi-Q 0.1 mg auto-injector is projected to be available for patients in the first half of 2018.
i Motosue M., et al. J Allergy Clin Immunol Pract. 2017;5:171-175.
ii Kim H., et al. Ann Allergy Asthma Immunol. 2017 Jun;118(6):719-725.
(Source: Kaléo, Inc.)
Filed Under: Drug Discovery