FDA Accepts Supplemental New Drug Application for Baloxavir Marboxil for Treating Flu in People at High Risk of Complications – APhA submits compounding comments to FDA. – (866) 348-2889.
Officials with the US Food and Drug Administration (FDA) have accepted a supplemental new drug application for baloxavir marboxil (Xofluza, Genentech) as a single-dose, oral treatment for people at high risk of complications from the flu, according to a statement from the manufacturer.
The sNDA 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 5 days, in people 12 years of age or older who are at high risk of complications from the flu. The study compared Xofluza with placebo and oseltamivir in 2184 people and measured the time to improvement of influenza symptoms.