The Food and Drug Administration (FDA) has granted Priority Review to the supplemental New Drug Application (sNDA) for AUVI-Q 0.1mg (Kaléo), the first epinephrine auto-injector designed to treat allergic reactions in infants who weigh 16.5 to 33 pounds. AUVI-Q, an epinephrine auto-injector, is currently FDA-approved in 0.15mg and 0.3mg formulations for the treatment of life-threatening allergic reactions, including anaphylaxis.
AUVI-Q 0.1mg was designed with a shorter needle length specifically for infants and small children to help mitigate the possibility of striking bone, which could potentially impact the administration of epinephrine during a life-threatening emergency.
“This newly designed and developed epinephrine auto-injector fulfills an important and timely unmet medical need for these infants and young children,” said Dr. Vivian Hernandez-Trujillo, a pediatric allergist, and fellow of the American Academy of Allergy, Asthma and Immunology.
The company has indicated that if the new auto-injector is approved they expect it to be available for patients in the first half of 2018.
For more information visit Auvi-q.com.