FDA Approves Epinephrine Auto-Injector for Infants, Small Children

Needle length and dose target patients weighing 16.5 to 33 pounds

The FDA has approved an 0.1-mg epinephrine auto-injector (Auvi-Q, kaléo), the first such device specifically designed for the treatment of life-threatening allergic reactions in infants and small children weighing 16.5 to 33 pounds who are at risk for or have a history of serious allergic reactions.

The 0.1-mg epinephrine auto-injector (EAI) has a shorter needle and lower dose of epinephrine than current FDA-approved 0.15-mg and 0.3-mg EAIs. Like other versions of Auvi-Q, the compact device has a voice prompt system that guides a user with step-by-step instructions through the delivery process and has a needle that automatically retracts following administration.

The indication for the new device includes anaphylaxis, a problem that increasingly affects children. There was a 130% increase in emergency room visits for anaphylaxis among children 4 years of age and younger between 2005 and 2014.

According to a study published in Allergy, Asthma & Clinical Immunology, 43% of children weighing 16.5 pounds (7.5 kg) to 33 pounds (15 kg) 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.  The needle length in Auvi-Q 0.1 mg was designed for use with infants and small children to help mitigate this safety concern.

"The approval of an epinephrine auto-injector specifically designed for infants and small children is timely, especially given the recent changes to guidelines recommending that certain high-risk infants, as young as 4 to 6 months old, be introduced to peanut-containing foods," said Eleanor Garrow-Holdingiii, President and CEO of the Food Allergy & Anaphylaxis Connection Team.

The Auvi-Q 0.1-mg auto-injector is projected to be available for patients in the first half of 2018.

The supplemental new drug application for the device was granted priority review by the FDA.

Source: kaléo; November 20, 2017.