US Food and Drug Administration grants priority review for new auto-injector specifically for small children

1^st August 2017

There is interesting news from America for parents and guardians of small children with severe allergies as pharmaceutical company Kaléo has announced that the US Food and Drug Administration has granted Priority Review of its supplemental New Drug Application for AUVI-Q 0.1 mg.

This is the first known epinephrine (adrenaline) auto-injector specifically designed for the treatment of life-threatening allergic reactions in infants and small children weighing 16.5 to 33 pounds (the equivalent of 7.5kg-15kg).

The priority review status means the FDA consider that the drug, if approved, may provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions compared to current available therapies.

The AUVI-Q Auto-injector is a prescription medicine used to treat life-threatening allergic reactions in people who are at risk for or who have a history of serious allergic reactions.

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. It is hoped the shorter needle length and lower dose will reassure parents and guardians who are wary of injecting too much epinephrine or hitting bone with a needle that may be too long for small children.

You can read the original press release here.