FDA Will Review New AUVI-Q Epinephrine Auto-Injector for Infants and Small Children

[Press Release]

U.S. FDA Grants Priority Review for an Epinephrine Auto-Injector in Development by Kaléo Specifically for Infants and Small Children

– AUVI-Q® (epinephrine injection, USP) 0.1 mg could be the first auto-injector approved with a needle length and dose specifically designed for infants and small children –

– Emergency room visits due to anaphylaxis are increasing in children –

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.


Read the full press release for more information.


Contact: Mark A. Herzog

kaléo

mark.herzog@kaleopharma.com

auviqmedia@kaleopharma.com

804-545-6360 (office) 


[i] Motosue M., et al. J Allergy Clin Immunol Pract. 2017;5:171-175.

[ii] Kim H., et al. Ann Allergy Asthma Immunol. 2017 Jun;118(6):719-725.

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