Posted by Michael Wonder on 26 Jun 2018
FDA grants priority review to Genentech’s baloxavir marboxil for the treatment of influenza
26 June 2018 - If approved, baloxavir marboxil would be the first oral, single-dose antiviral and the first medicine with a novel proposed mechanism of action to treat the flu in nearly 20 years.
Genentech today announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) and granted Priority Review for baloxavir marboxil as a single-dose, oral treatment for acute, uncomplicated influenza in people 12 years and older. The FDA is expected to make a decision on approval by December 24, 2018.
The NDA is based on results from the Phase III CAPSTONE-1 study of a single dose of baloxavir marboxil compared with placebo or oseltamivir 75 mg, twice daily for five days, in otherwise healthy people with the flu. Additionally, results from a placebo-controlled Phase II study in otherwise healthy people with the flu are included as supporting data in the NDA.
