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U.S. FDA Approves Life-Threatening Allergic Reaction Treatment

The epinephrine auto-injector is specifically designed for infants and small children

By: Betsy Louda

, Contract Pharma

Kaléo Pharma, a privately-held pharmaceutical company, has received FDA approval of its its supplemental New Drug Application for the AUVI-Q 0.1 mg Auto-Injector, the first of its kind in the industry specifically designed for the treatment of life-threatening allergic reactions in infants and small children weighing 16.5 to 33 pounds.

 

This news comes after the treatment was granted Priority Review by the FDA. 


AUVI-Q is a compact auto-injector with features that include a voice prompt system that guides a user with step-by-step instructions through the delivery process, and a needle that automatically retracts following administration. The new 0.1 mg-dose epinephrine auto-injector has a shorter needle length and lower dose of epinephrine than current FDA approved 0.15 mg and 0.3 mg epinephrine auto-injectors.

 

“Today’s decision by the FDA to approve the AUVI-Q 0.1 mg Auto-injector is exciting for all of us in the life-threatening allergy community who have been working for many years to fulfill this unmet medical need,” said Spencer Williamson, president and chief executive officer of kaléo.
 

There was a 129.8 percent increase in emergency room visits for anaphylaxis among children four years old and younger between 2005 and 2014, further demanding new treatments like this for life-threatening allergies.

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