Pharmaceutical company kaléo reported on Monday the receipt of US Food and Drug Administration (FDA) approval for its supplemental New Drug Application (sNDA) for AUVI-Q (epinephrine injection, USP) in 0.1 mg for the treatment of life-threatening allergic reactions, including anaphylaxis.

Anaphylaxis is reportedly a serious allergic reaction that happens quickly and may cause death. Anaphylaxis can occur as a result of exposure to allergens including tree nuts, peanuts, milk, eggs, fish, shellfish, soy, wheat, insect bites, latex and medication, among other allergens.

According to a study published in Allergy, Asthma & Clinical Immunology, 43% of children weighing 16.5 pounds to 33 pounds treated with a 0.15 mg EAI having a standard 12.7 mm needle length are at risk of having the needle strike the bone.

Only AUVI-Q 0.1 mg has a dose and needle length designed specifically for treating anaphylaxis in infants and small children weighing 16.5 - 33 pounds. AUVI-Q 0.1 mg includes the innovative AUVI-Q electronic voice instruction system as well as visual cues to help guide users step-by-step through the administration.

The company's new 0.1 mg-dose epinephrine auto-injector has a shorter needle length and lower dose of epinephrine than current US FDA approved 0.15 mg and 0.3 mg epinephrine auto-injectors. The sNDA for the AUVI-Q 0.1 mg Auto-injector was granted Priority Review by the US FDA.