FDA Approves Auvi-Q with Lower Dose for Infants and Small Children

Today, kaléo announced the US Food and Drug Administration (FDA) has approved its supplemental New Drug Application for AUVI-Q® 0.1 mg, the first epinephrine auto-injector specifically designed for the treatment of life-threatening allergic reactions in infants and small children weighing 16.5 to 33 pounds at risk for or have a history of serious allergic reactions.
Children are increasingly being treated for anaphylaxis with a 129.8% increase in emergency room visits for anaphylaxis among children four years old 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 kilograms) to 33 pounds (15 kilograms) 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 specifically designed for use with infants and small children to help mitigate this safety concern.

“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,” said Dr Vivian Hernandez-Trujillo, a 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. “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 AUVI-Q 0.1 mg Auto-injector is projected to be available for patients in the first half of 2018.