by from the Food and Drug Administration’s Division of Pulmonary, Allergy and Rheumatology Products, Office of Pediatric Therapeutics, and Division of Pediatric and Maternal Health
The Food and Drug Administration (FDA) has approved a new lower dose epinephrine auto-injector for the
emergency treatment of allergic reactions in infants and toddlers.
This is the first-ever epinephrine auto-injector designed for infants and small children who weigh between 16.5 to 33 pounds.
Auto-injector maker Kaléo developed the new device, called Auvi-Q 0.1 mg, which is expected to be available in the first half of 2018. The device has a smaller dose of epinephrine and the needle length is shorter than the 0.15 mg and 0.3 mg auto-injectors for children and adults that are already on the market.
The company developed the Auvi-Q 0.1 mg auto-injector “with a shorter needle length to help mitigate the risk of striking bone which could potentially cause injury or interfere with the delivery of epinephrine,” said Dr. Eric Edwards, vice president of Innovation and Research & Development at Kaléo, in a press release issued November 20.
A study published in Allergy, Asthma & Clinical Immunology found that 43 percent of children weighing 16.5 to 33 pounds treated with a 0.15 auto-injector with a 12.7 millimeters needle length were at risk of having the needle hit the bone. The team behind that research had urged the development of an infant epinephrine auto-injector, and when Kaléo came forward with an infant device, the FDA fast-tracked its review.
The new device includes the unique voice-guided instructions, which Kaléo also employs with its two other Auvi-Q devices, as well as a needle that retracts after the epinephrine is administered. The needle length is considerably shorter than the standard auto-injector, measuring 7.4 mm instead of 12.7 mm (about half an inch). It will be sold as a pack of two plus a trainer auto-injector.