Posted by Michael Wonder on 07 Mar 2019
FDA accepts Genentech’s supplemental new drug application for Xofluza (baloxavir marboxil) for the treatment of influenza in people at high risk of complications
5 March 2019 - Xofluza would be the first antiviral medicine approved specifically for the high-risk population.
Genentech today announced that the U.S. FDA has accepted a supplemental new drug application for Xofluza (baloxavir marboxil) as a single-dose, oral treatment for people at high risk of complications from the flu. The FDA is expected to make a decision on approval by 4 November 2019.
The sNDA is based on results from the Phase III CAPSTONE-2 study of a single dose of Xofluza compared with placebo or oseltamivir 75 mg, twice daily for five days, in people 12 years of age or older who are at high risk of complications from the flu.
