FDA approve Auvi-Q (Sanofi) for Anaphylaxis

The FDA has approved Auvi-Q (epinephrine injection, USP), from Sanofi, for the emergency treatment of life-threatening Allergic reactions in people who are at risk for or have a history of Anaphylaxis. Auvi-Q is the first-and-only compact epinephrine auto-injector with audio and visual cues that guide patients and caregivers step-by-step through the injection process.

Auvi-Q is the size and shape of a credit card, the thickness of a cell phone and fits comfortably in a pocket or small purse. During a life-threatening allergic reaction, Auvi-Q talks the user through each step of the injection process. If the patient or caregiver needs more time, it repeats the step-by-step directions. Alternatively, a patient or caregiver can move at their own pace by following the written instructions printed on the device.

Sanofi US licensed the North American commercialization rights to Auvi-Q from Intelliject, Inc., which has retained commercialization rights for the rest of the world. The approval is based on a bioequivalence clinical study, conducted using Auvi-Q and EpiPen. Both auto-injectors delivered 0.3mg of epinephrine. Injections with epinephrine using Auvi-Q were well-tolerated and resulted in epinephrine plasma concentration levels that were found to be bioequivalent to EpiPen. Auvi-Q is available in 2 doses: 0.15mg and 0.3 mg.