FDA approves Kaleo’s epinephrine auto-injector for infants and children

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The U.S. Food and Drug Administration (FDA) has approved Richmond-based Kaléo’s supplemental drug application for the first epinephrine auto-injector specifically for infants and children with serious allergic reactions.

The AUVI-Q 0.1mg is designed to treat life-threatening allergic reactions for children who weigh between 16.5 and 33 pounds.

The company’s auto-injector received priority review by the FDA, an expedited regulatory pathway.

Children who are treated with a standard needle length are at risk of having the needle strike the bone, according to a study published in Allergy, Asthma & Clinical Immunology. Kaléo’s AUVI-Q 0.1 mg also provides a lower dosage of epinephrine.

AUVI-Q includes a voice prompt system that guides users with instructions on how to use the injector and a needle that automatically retracts following administration.

"Until now, health-care 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," 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, said in a statement. "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."

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