Sanofi Announces FDA Approval For Auvi-Q™, First Voice-guided Epinephrine Auto-injector For Anaphylaxis
Breakthrough device design talks patients and caregivers through the injection process
Sanofi (EURONEXT: SAN and NYSE: SNY) 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.
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 US. “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.”
About Auvi-Q™
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.
Clinical Study Background
A bioequivalence clinical study was conducted using Auvi-Q (epinephrine injection, USP) 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®.
About Anaphylaxis
Anaphylaxis (pronounced ana-fuh-lax-is) is a serious allergic reaction that happens quickly and may cause death. It can occur as a result of exposure to allergens including nuts, shellfish, dairy, eggs, insect bites, latex and medication, among other allergens. Food is the most commonly-identified anaphylaxis trigger and accounts for 30 percent of all anaphylaxis fatalities.
About Sanofi
Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Sanofi is the holding company of a consolidated group of subsidiaries and operates in the United States as Sanofi US, also referred to as sanofi-aventis U.S. LLC. For more information on Sanofi US, please visit www.sanofi.us or call 1-800-981-2491.
Source: Sanofi