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# Genentech sNDA for Xofluza Expanded Use
- URL: https://www.fdaweb.com/genentech-snda-for-xofluza-expanded-use/
- Published: 2019-03-06T12:00:00.000Z
- Updated: 2026-09-15T01:10:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143536

FDA has accepted for review a Genentech supplemental NDA for Xofluza (baloxavir marboxil) as a single-dose, oral treatment for people at high risk of complications from the flu. FDA approved the therapy 10/2018 for treating acute, uncomplicated influenza in people 12 years of age or older. The agency has set a user fee review action target of 11/4.

The submission is based on results from the Phase 3 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. Data showed that the drug significantly reduced the time to improvement of influenza symptoms versus placebo in people at high risk of complications from influenza (median time 73.2 hours versus 102.3 hours), the company says. They also showed superior efficacy (reduced time to improvement of influenza symptoms) versus placebo and oseltamivir in influenza Type B (median time of 74.6 hours versus 100.6 hours and 101.6 hours, respectively).