FDA Approves AUVI-Q for Infants and Small Children

The US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for epinephrine injection (AUVI-Q) 0.1 mg specifically designed for the treatment of life-threatening allergic reactions in infants and small children weighing 16.5—33 pounds who are at risk or have a history of serious allergic reactions, announced kaleo.

The auto-injector was granted priority review by the FDA, as this is the first and only device that has a dose and needle length designed specifically for treating anaphylaxis in infants and small children. AUVI-Q 0.1 mg includes the innovative AUVI-Q electronic voice instruction system and visual cues to help guide users step-by-step through the administration of the auto-injector.

"Until now, healthcare practitioners and caregivers to infants and small children have not had an epinephrine auto-injector with an appropriate dose of epinephrine available to them, potentially causing some delay in the administration of epinephrine in a life-threatening allergic emergency," Vivian Hernandez-Trujilloiii, MD, pediatric allergist, and fellow of the American Academy of Allergy, Asthma and Immunology; American College of Allergy, Asthma and Immunology; and American Academy of Pediatrics specializing in the management of life-threatening allergies and anaphylaxis, said in a statement. "Having an epinephrine auto-injector with a needle length and dose specifically designed for infants and small children should help alleviate concerns around hitting the bone or injecting too much epinephrine."

The prescription medicine is used to treat life-threatening allergic reactions, including anaphylaxis. It contains epinephrine, a first-line treatment for severe, life-threatening allergic reactions that occur as a result of exposure to allergens.

AUVI-Q is a compact epinephrine auto-injector with industry-first features which includes a voice prompt system that guides a user with step-by-step instructions, and a needle that automatically retracts following administration. The new dose has a shorter needle length and lower dose of epinephrine than current FDA approved 0.15 mg and 0.3 mg epinephrine auto-injectors.

It’s projected to be available for patients in the first half of 2018.

A press release has been made available.

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