An exciting day.
Today the FDA approved Tamiflu as the first anti-viral that may be used to treat influenza in children under the age of one year.
According to the CDC, infants are especially vulnerable to developing complications from influenza and those 6 months of age and younger have the highest rates of hospitalization.
Conducting clinical trials in such vulnerable patients is extremely complex, yielding low patient numbers, and requires novel approaches in order to identify dosing recommendations.
In this case, it was through the longstanding (since 2006) successful collaboration between NIH Collaborative Antiviral Study Group (CASG) and Roche. Each group conducted dedicated clinical studies, yielding a total of 135 children under 1 year old with confirmed cases of the flu. These investigations provided safety information for Tamiflu in infants, and innovative clinical pharmacology strategies were applied to assist with defining dose recommendations.