FDA approves Intelliject's Auvi-Q for anaphylaxis

Intelliject, Inc. announced that the U.S. Food and Drug Administration (FDA) approved Auvi-Q™ (epinephrine injection, USP) for the emergency treatment of life-threatening allergic reactions in people who are at risk or have a history of anaphylaxis. This is the first-and-only compact auto-injector with audio and visual cues that guide patients and caregivers step-by-step through the injection process.

“We are building on this approval and have a pipeline of drug/device combination products for select therapy areas.”

Eric and Evan Edwards, twin brothers who jointly founded Intelliject and who themselves suffer from severe, life-threatening allergies, developed Auvi-Q with a team of world-class engineers and scientists using a comprehensive Human Factors Engineering process. This development process incorporated real-world experiences and feedback from patients and caregivers.

"In developing Auvi-Q, our goal is to offer patients and caregivers an innovative treatment option that is easy to use in an emergency," said Eric Edwards, Chief Science Officer, Intelliject, Inc. "As allergy sufferers, my twin brother and I know first-hand how stressful it can be when you experience a severe allergic reaction. Auvi-Q's small size and intuitive design, as well as its first-in-class prompt system that talks a user through the injection process, will help patients and caregivers manage a life-threatening allergic reaction."

Auvi-Q contains epinephrine, the 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, and others.

"The FDA approval of Auvi-Q is an important milestone for the company and is a result of our steadfast commitment to developing patient-centric products," said Spencer Williamson, President and Chief Executive Officer, Intelliject, Inc. "We are building on this approval and have a pipeline of drug/device combination products for select therapy areas."

Intelliject, Inc. was responsible for the development and regulatory submission of Auvi-Q in the U.S. Sanofi US is responsible for manufacturing and commercial activities in North America (U.S. and Canada).