FDA Grants Kaléo Priority Review for AUVI-Q 0.1 mg

15:37 EDT 27 Jul 2017 | Virginia Biotechnology

Kaléo, a privately-held pharmaceutical company, was granted Priority Review by the U.S. Food and Drug Administration (FDA) 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. 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. 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, 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.

Original Article: FDA Grants Kaléo Priority Review for AUVI-Q 0.1 mg


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