FDA Approves Sanofi’s Auvi-Q™ Voice-guided Epinephrine Auto-injector

In short

U.S. FDA has approved Sanofi’s Auvi-Q 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.

Background

Auvi-Q (epinephrine injection, USP) is used to treat life-threatening allergic reactions (anaphylaxis) in people who are at risk for or have a history of these reactions. 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.

Eric and Evan Edwards, twin brothers who suffer from life-threatening allergies, and co-founders of Intelliject, Inc.*, developed Auvi-Q with a team of world-class engineers and scientists. The development process incorporated real-world experiences and feedback from patients and caregivers.

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.

Auvi-Q provides users with audible and visual cues, including a five-second injection countdown and an alert light to signal when the injection is complete. In addition to being an auto-injector, Auvi-Q features an automatic retractable needle mechanism to help prevent accidental needle sticks.

While recently updated guidelines emphasize the importance of the life-saving role of epinephrine, surveys showed that two-thirds of patients and caregivers do not carry their epinephrine auto-injectors as recommended and nearly half worry that others will not know how to use their device during an emergency.

Auvi-Q contains epinephrine, a well-established, first-line treatment for severe, life-threatening allergic reactions that may occur as a result of exposure to allergens including nuts, shellfish, dairy, eggs, insect bites, latex and medication, among other allergens.

Clinician comments

“The first step in preventing a severe allergic reaction is always avoidance of the specific allergen,” said Dr. Vivian Hernandez-Trujillo, a pediatric allergist and national expert in anaphylaxis. “However, in the event of a life-threatening allergic reaction, it’s important to know how to respond quickly. Auvi-Q offers patients and caregivers guidance through the injection process.”

Company comments 

“As a company committed to patient-centered care, our focus is on creating innovative solutions that make a difference in the lives of people,” said Anne Whitaker, President, North America Pharmaceuticals, Sanofi. “Auvi-Q delivers on this by offering a state-of-the-art epinephrine auto-injector device that addresses the needs of patients at risk for life-threatening allergic reactions and their caregivers.”

“With this FDA approval, Auvi-Q will become the first-and-only epinephrine auto-injector that talks users through each step of the injection process,” said Bryan Downey, Vice President, Auvi-Q, Sanofi US. “We are confident that Auvi-Q will provide the up to six million Americans at risk for anaphylaxis and their caregivers an easy-to-use, compact option with unique features to help manage a life-threatening allergic reaction.”

* Sanofi US licensed the North American commercialisation rights to Auvi-Q from Intelliject, Inc., which has retained commercialisation rights for the rest of the world.

Source: Sanofi, PR Newswire