FDA Clears First Epinephrine Autoinjector for Infants

Megan Brooks


November 21, 2017

The US Food and Drug Administration (FDA) has approved the first and only epinephrine autoinjector (EAI) specifically designed for the treatment of life-threatening allergic reactions, including anaphylaxis, in infants and children weighing 16.5 to 33 pounds (7.5 to 15 kg), according to a company statement.

Approval of the supplemental new drug application (sNDA) for Auvi-Q (epinephrine injection, USP) 0.1 mg was granted to Kaléo pharmaceutical company after priority review.

"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," the company explained in a news release.

"The approval of Auvi-Q 0.1 mg will help achieve our goal of working to fulfill unmet medical needs," Eric S. Edwards, MD, PhD, vice president of innovation and research and development at Kaléo, said in the release.

"We developed the Auvi-Q 0.1 mg EAI to deliver a dose of epinephrine appropriate to infants and small children weighing 16.5 to 33 pounds, with a shorter needle length to help mitigate the risk of striking bone, which could potentially cause injury or interfere with the delivery of epinephrine," he added.

Eleanor Garrow-Holding, president and CEO of the Food Allergy and Anaphylaxis Connection Team, said the approval of an EAI 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. We are pleased that the pediatric allergy healthcare community and parents of infants and small children with life-threatening allergies will have the ability to obtain an FDA-approved epinephrine autoinjector in the event of an allergic emergency."

"Until now, healthcare practitioners and caregivers to infants and small children have not had an epinephrine autoinjector with an appropriate dose of epinephrine available to them, potentially causing some delay in the administration of epinephrine in a life-threatening allergic emergency," added Vivian Hernandez-Trujillo, MD, pediatric allergist and fellow of the American Academy of Allergy, Asthma, and Immunology. "Having an epinephrine autoinjector 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 company expects the Auvi-Q 0.1 mg autoinjector to be available in the first half of 2018. Full prescribing information and patient guide are available online.

For more news, join us on Facebook and Twitter


Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.
Post as: