The FDA has approved Kaleo‘s Auvi-Q epinephrine auto-injector designed to treat life-threatening allergic reactions in infants and small children, according to the privately-held biopharma company.
The device, which Kaleo touts as the first of its kind, was given priority review by the FDA.
The 0.1 mg Auvi-Q auto-injector has a shorter needle and a lower dose of epinephrine compared to the company’s 0.15 mg and 0.3 mg devices. The injector includes a voice prompt system that gives the user step-by-step instructions, as well as a needle that automatically retracts after administration.
“Today’s decision by the FDA to approve the Auvi-Q 0.1 mg auto-injector is exciting for all of us in the life-threatening allergy community who have been working for many years to fulfill this unmet medical need,” president & CEO Spencer Williamson said in prepared remars.
“As a company that focuses on patients first, and providing potentially life-saving treatments, we are particularly glad we will be able to help caregivers by providing an EAI that was specifically designed with an appropriate dose and needle length for infants and children (16.5 to 33 pounds) in order to maximize the potential for a safe administration of epinephrine.”
“The approval of Auvi-Q 0.1 mg will help achieve our goal of working to fulfill unmet medical needs,” Dr. Eric Edwards, VP of innovation and R&D, added. “We developed the Auvi-Q 0.1 mg EAI to deliver a dose of epinephrine appropriate to infants and small children weighing 16.5 – 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.”
“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,” pediatric allergist Dr. Vivian Hernandez-Trujillo said. “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.”