Baloxavir marboxil filed with FDA and given priority review in influenza.- Genentech/Roche.

Genentech/Roche announced that the 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. A Priority Review designation is granted to medicines that the FDA has determined to have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease.

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.

Comment: Baloxavir marboxil was approved in February 2018 by the Japanese Ministry of Health, Labour and Welfare for the treatment of influenza types A and B in adult and pediatric patients, and is being commercialized in Japan and marketed under the brand name Xofluza.