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.
The AUVI-Q 0.1 mg Auto-injector is projected to be available for patients in the first half of 2018.