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First epinephrine auto-injector for infants and children approved by FDA

The US Food and Drug Administration (FDA) has approved the Auvi-Q (epinephrine injection USP) 0.1mg auto-injector as a treatment for life-threatening allergic reactions in children and infants. The Kaléo product was granted Priority Review by the FDA and is expected to be available in American pharmacies within first six months of 2018.

The Auvi-Q boasts a number of new features not found in any similar products, including a voice prompt system to guide users in the delivery process, and a needle that automatically retracts once it has been used. It features a smaller needle than other auto-injectors, such as the Adrenaclick and EpiPen, and administers a smaller dose than existing 0.15mg and 0.3mg devices. The smaller needle alleviates some of the risk involved when administering epinephrine to smaller patients, such as delivering too much of the drug or hitting the bone. 

Eleanor Garrow-Holding, president and chief executive officer of the Food Allergy & Anaphylaxis Connection Team, commented: “The approval of an epinephrine auto-injector specifically designed for infants and small children is timely, especially given the recent changes to guidelines recommending that certain high-risk infants, as young as four to six months old, be introduced to peanut-containing foods.”

Epinephrine is used to treat anaphylaxis and serious allergic reactions to substances and foodstuffs like milk, nuts, shellfish, soy, insect bites, latex, and fish, among others. Auvi-Q is indicated for children weighing between 16.5 and 33 pounds who are at risk from serious allergic reactions. The drug was granted Priority Review by the FDA as it fulfills a previously unmet medical need. 

In June 2017, the FDA also approved the Adamis Pharmaceuticals Epinephrine Injection, which goes by the trade name Symjepi, for the emergency treatment of allergic reactions including anaphylaxis. Researchers estimate up to 15 million people in the United States have a food allergy, according to the National Institute of Allergy and Infectious Diseases. Every year, around 200,000 people require emergency medical care for allergic reactions to food.