Auvi-Q™, First Voice-Guided Epinephrine Auto-Injector For Patients With Life-Threatening Allergies, Receives FDA Approval

Breakthrough device design talks patients and caregivers through the injection process

Sanofi (EURONEXT: SAN and NYSE: SNY) have announced 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. “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.

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.

        Indication

Auvi-Q (epinephrine injection, USP) is indicated in the emergency  treatment of allergic reactions (Type I) including anaphylaxis to allergens, idiopathic  and exercise-induced anaphylaxis. Auvi-Q is intended for individuals with a history of anaphylaxis or who are at risk for anaphylactic reactions.

        Important Safety Information

Auvi-Q should ONLY be injected into the anterolateral aspect of  the thigh. DO NOT INJECT INTO BUTTOCK OR INTRAVENOUSLY.

Epinephrine should be administered with caution to patients with certain heart diseases,  and in patients who are on medications that may sensitize the heart to arrhythmias, because it may precipitate or aggravate angina pectoris and produce ventricular arrhythmias. Arrhythmias, including fatal ventricular fibrillation, have been reported  in patients with underlying cardiac disease or taking cardiac glycosides or diuretics. Patients with certain medical conditions or who take certain medications for allergies, depression, thyroid disorders, diabetes, and hypertension, may be at greater risk for adverse reactions. Adverse reactions to epinephrine include anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea  and vomiting, headache, and/or respiratory difficulties.

Auvi-Q is intended for immediate self-administration as emergency supportive therapy  only and is not a substitute for immediate medical or hospital care.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088

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