Sanofi announced today that the U.S. Food and Drug Administration (FDA) has approved Auvi-Q (epinephrine injection, USP) 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.
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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.
“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.”
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.
“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.”
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.
“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.”