Kaleo said Monday that the Food and Drug Administration has approved its supplemental New Drug Application (sNDA) for Auvi-Q 0.1 mg, which can be used to treat life-threatening allergic reactions, including anaphylaxis, in children weighing 16.5 to 33 pounds. The Auvi-Q 0.1 mg sNDA received priority review from the FDA.
A compact epinephrine auto-injector, the Auvi-Q 0.1 mg has 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, according to Kaleo. The company said the new 0.1 mg-dose auto-injector has a shorter needle length and lower dose of epinephrine than its current FDA-approved 0.15 mg and 0.3 mg epinephrine auto-injectors.
“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,” stated Spencer Williamson, president and chief executive officer of Kaleo. “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.”
Kaleo said only the Auvi-Q 0.1 mg has a dose and needle length designed specifically for treating anaphylaxis in infants and small children weighing 16.5 to 33 pounds. The company reported that children are increasingly being treated for anaphylaxis, with a 129.8% Rise in emergency room visits among kids ages 4 and younger between 2005 and 2014. What’s more, 43% of children weighing 16.5 pounds to 33 pounds treated with a 0.15 mg auto-injector with a standard 12.7-mm needle length are at risk of having the needle strike the bone, potentially impacting the administration of epinephrine during an emergency.
“The approval of Auvi-Q 0.1 mg will help achieve our goal of working to fulfill unmet medical needs,” commented Eric Edwards, vice president of innovation and R&D at Kaleo. “We developed the Auvi-Q 0.1 mg EAI [epinephrine auto-injector] 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.”
Plans call for the Auvi-Q 0.1 mg auto-injector to become available to patients in the first half of 2018.