Roche Announces FDA Approval of Xofluza (Baloxavir Marboxil), a First-in-Class Single-Dose Oral Treatment for Influenza

Yiyao.com, October 26 — Swiss pharmaceutical giant Roche recently announced that the U.S. Food and Drug Administration (FDA) has approved Xofluza (baloxavir marboxil), a single-dose oral medication for the treatment of acute, uncomplicated influenza in patients aged 12 years and older. This approval makes Xofluza the first anti-influenza drug with a novel mechanism of action in nearly two decades. In clinical trials, a single dose of Xofluza significantly reduced the duration of influenza symptoms and markedly decreased viral shedding within just one day.

 

The approval of Xofluza was based on the results of the Phase III clinical study CAPSTONE-1. This study was a global, multicenter, randomized, double-blind, placebo-controlled Phase III trial that enrolled 1,436 patients in the United States and Japan, ranging in age from 12-year-old children to 64-year-olds.Elderly, a single dose of Xofluza was compared with placebo and Tamiflu (75 mg twice daily for 5 days). The primary endpoint was time to alleviation of symptoms (TTAS), and key secondary endpoints included time to fever resolution, time to cessation of viral shedding, proportion of subjects with positive influenza virus titers, and in vivo viral load.

 

The results showed that, compared with placebo, Xofluza met both the primary and secondary endpoints: (1) significantly reducing the duration of influenza symptoms by more than one day (median time: 53.7 hours vs. 80.2 hours, p<0.001); (2) significantly shortening the duration of fever by nearly one day (median time: 24.5 hours vs. 42.0 hours, p<0.001); (3) significantly reducing the duration of viral shedding (median duration of viral shedding: 24.0 hours vs. 96.0 hours, p<0.001); and (4) significantly lowering nasal and pharyngeal viral loads from 24 hours (Day 1) to 120 hours (Day 5) post-treatment.

 

Compared with Tamiflu, Xofluza demonstrated similar efficacy in terms of symptom duration and fever reduction, but a significant difference favoring Xofluza was observed in the time to cessation of viral shedding: (1) no significant reduction in symptom duration (median time: 53.5 hours vs. 53.8 hours, p=0.7560); (2) no significant reduction in fever duration (median time: 24.4 hours vs. 24.0 hours, p=0.9225); (3) a significant reduction in the duration of viral shedding (viral shedding: 24.0 hours vs. 72.0 hours, p<0.001); (4) a significant reduction in nasal and pharyngeal viral levels from 24 hours (Day 1) to 120 hours (Day 5) post-treatment.

 

In this study, Xofluza was well tolerated, with an overall incidence of adverse events (20.7%) slightly lower than that in the placebo group (24.6%) and the Tamiflu group (24.8%). The most common adverse events in the Xofluza treatment group were diarrhea (3%), bronchitis (2.6%), nausea (1.3%), and sinusitis (1.1%), all of which occurred at lower rates than in the placebo group.

 

Xofluza: The Super Flu Drug, One Oral Dose Kills the Virus Within 24 Hours

 

Influenza is one of the most common yet serious infectious diseases, posing a threat to publicHealthposing a significant threat. Globally, annual epidemics result in 3 to 5 million cases of severeDisease, with millions hospitalized and up to 650,000 deaths.

 

Xofluza is a first-in-class, single-dose investigational oral medication with a novel anti-influenza mechanism of action distinct from other antiviral drugs currently on the market. As an endonuclease inhibitor, Xofluza is designed to inhibit the cap-dependent endonuclease in the influenza virus, an enzyme essential for viral replication. Xofluza is intended to combat both influenza A and B viruses, including oseltamivir (Tamiflu)-resistant strains and avian influenza strains (H7N9, H5N1). Tamiflu, developed by Gilead Sciences and commercially distributed globally by Roche, is currently a widely used oral anti-influenza medication that typically requires multiple days of administration, twice daily, with onset of action usually taking 72 hours.

 

Xofluza can eliminate the influenza virus within 24 hours, although some symptoms may persist for a longer duration. As Xofluza requires only a single oral dose and is suitable for both adults and children, it offers considerable convenience, leading to a substantial improvement in patient adherence.

 

In July this year, Roche announced that the global Phase III clinical study CAPSTONE-2, which evaluated the efficacy and safety of Xofluza in individuals aged 12 years and older at high risk for influenza complications, had met its primary endpoint and demonstrated superior efficacy. Currently, Xofluza is being evaluated in a Phase III clinical development program, includingChildrenpopulations, post-exposure prophylaxis, and patients hospitalized with severe influenza; its potential to reduce transmission in other healthy populations is also being evaluated.

 

Baloxavir marboxil was discovered by the Japanese pharmaceutical company Shionogi and is being jointly developed globally by Roche and Shionogi. Under the agreement, Roche holds global rights to the drug in all regions except Japan and Taiwan, China. In February this year, baloxavir marboxil was approved by the Japanese Ministry of Health, Labour and Welfare (MHLW) for sale in Japan under the brand name Xofluza, for the treatment of influenza A and B in adult and pediatric patients.

 

Article reference source: Roche announces FDA approval of Xofluza (baloxavir marboxil) for influenza