14 August 2012 | Regulatory | By BioSpectrum Bureau
US FDA nod to epinephrine auto-injector with audio, visual cues
Auvi-Q is the first-and-only compact epinephrine auto-injector with audio and visual cues
Singapore: The US 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, 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 Ms 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 lifethreatening 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 Mr 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, lifethreatening 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.