Recently, the U.S. Food and Drug Administration (FDA) approved a New Drug Application for an epinephrine auto-injector (EAI) designed for use with the very young.
The AUVI-Q 0.1 mg auto-injector, manufactured by kaléo, was created to treat severe food reactions in infants and children weighing 16.5 to 33 pounds. The new auto-injector addresses the issue of needle length raised by a study published in Allergy, Asthma & Clinical Immunology.
The study revealed that 43 percent of infants and young children treated with standard 0.15 mg EAIs were at risk of having the 12.7 mm needle strike bone, affecting the epinephrine’s delivery during an allergy emergency. The new AUVI-Q for small children has a shorter needle length to help alleviate this safety concern.
Epinephrine in the newly approved AUVI-Q is also dosed for infants and small children. Fear of giving young children more epinephrine than their body requires has delayed the use of EAIs in some life-threatening situations—a fear the new AUVI-Q removes.
“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…in order to maximize the potential for a safe administration of epinephrine,” says Spencer Williamson, kaléo’s President, and CEO.
Approval of the 0.1 mg auto-injector is timely given the new recommendations for introducing certain high-risk infants to peanut-containing foods. Parents can feel more confident about following the recommendations knowing a correctly dosed EAI is at hand.
Like the standard AUVI-Q for older children and adults, the infant version includes electronic voice instruction and visual cues for the auto-injector’s use. The AUVI-Q 0.1 mg auto-injector will likely be available to patients by June, 2018.