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Richmond, VA (July 27, 2017) Kaléo, a privately-held pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review of its supplemental New Drug Application (sNDA) for AUVI-Q 0.1 mg, the first known epinephrine auto-injector specifically designed for the treatment of life-threatening allergic reactions in infants and small children weighing 16.5 to 33 pounds. The new 0.1 mg dose epinephrine auto-injector has a shorter needle length and lower dose than existing 0.15 mg and 0.3 mg epinephrine auto-injectors.

Priority Review designation by the FDA is given to drugs that, if approved, may provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to available therapies.

Children are increasingly being treated for anaphylaxis. There was a 129.8 percent increase in emergency room visits for anaphylaxis among children four years old and younger between 2005 and 2014.[i] According to a study published in Allergy, Asthma & Clinical Immunology, 43 percent of children weighing 16.5 pounds (7.5 kg) to 33 pounds (15 kg) treated with a 0.15 mg auto-injector having a standard 12.7 mm needle length are at risk of having the needle strike the bone, therefore potentially impacting the administration of epinephrine during a life-threatening emergency.[ii] The needle length in AUVI-Q 0.1 mg was specifically designed for use with infants and small children to help mitigate this safety concern.

“National Institutes of Health (NIH) guidelines now recommend that certain infants be evaluated for potential peanut allergy and early peanut introduction as young as four to six months old,” said Eleanor Garrow-Holding, President and CEO of the Food Allergy & Anaphylaxis Connection Team (FAACT). “We applaud the development of the first epinephrine auto-injector (EAI) specifically designed to treat infants and small children who may be at risk for peanut or other life-threatening allergies. As there is currently no EAI on the market specifically designed for this precious population, we hope that the AUVI-Q 0.1 mg is approved as soon as possible.”

“Children continue to be diagnosed with life-threatening allergies at an earlier age, some as young as a few months,” said Dr. Vivian Hernandez-Trujillo[iii], a pediatric allergist, and fellow of the American Academy of Allergy, Asthma and Immunology; American College of Allergy, Asthma and Immunology; and American Academy of Pediatrics specializing in the management of life-threatening allergies or anaphylaxis. “Until now, the needle length and dose of available epinephrine auto-injectors have given caregivers pause — wary of injecting too much epinephrine or hitting bone with a needle that may be too long for small children. This newly designed and developed epinephrine auto-injector fulfills an important and timely unmet medical need for these infants and young children.”

AUVI-Q 0.1 mg builds upon kaléo’s continued commitment to innovation. “Kaléo is proud to be taking a leadership role in helping to fulfill this unmet medical need that has been identified for over a decade by parents of young children and the pediatric allergy healthcare practitioner community,” said Spencer Williamson, President and CEO of kaléo.

“The AUVI-Q 0.1 mg Auto-injector in development not only contains a dose of epinephrine tailored to infants and small children, but contains important product features such as an optimized needle length designed to help mitigate the risk of striking bone in this population,” said Eric S. Edwards, MD, PhD, Vice President of Innovation and Research & Development at kaléo.

AUVI-Q (0.15 mg and 0.3 mg) is a FDA-approved prescription medicine used to treat life-threatening allergic reactions, including anaphylaxis, in people who are at risk for or have a history of serious allergic reactions. It is an epinephrine auto-injector with innovative features such as voice instructions that help guide a user with step-by-step instructions through the epinephrine delivery process and an automatic retractable needle system, a first for epinephrine auto-injectors, that injects the epinephrine and retracts the needle back into the device within seconds.

The approval and launch of AUVI-Q was initially delayed due to a patent lawsuit filed by the makers of EpiPen®. The lawsuit was resolved in 2012 allowing for the commercialization and launch of AUVI-Q. Therefore, kaléo does not expect a similar legal delay in approval of AUVI-Q 0.1 mg.

Identical twin brothers, Evan and Eric Edwards, the inventors of AUVI-Q, grew up with life-threatening allergies. They know what it is like to live with life-threatening allergies, both as patients and parents of food-allergic children. Their goal was to develop an epinephrine auto-injector that contained innovative features, such as a voice instruction system that helps guide patients and caregivers step-by-step through the injection process. Evan and Eric Edwards believe and trust in AUVI-Q, not only for themselves, but also for their children and other families who may have to depend on it to administer epinephrine during an allergic emergency.

If approved, the new AUVI-Q 0.1 mg Auto-injector is projected to be available for patients in the first half of 2018.

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