Xofluza Beats Tamiflu in Phase 3 Clinical Study

The results of the phase III CAPSTONE-2 study showed treatment with Xofluza (baloxavir marboxil) significantly reduced the time to the improvement of influenza symptoms versus placebo. 

The median time of Xofluza improvement was 73.2 hours versus 102.3 hours in people at high risk of serious complications from the flu. 

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Influenza, or flu, is one of the most common, yet serious, infectious diseases. For people who are considered at high risk of serious complications, like pneumonia and bronchitis, the flu can worsen existing health problems, lead to hospitalization or even death, says the CDC.

Those at high risk include adults 65 years of age or older, or those who have conditions such as asthma, chronic lung disease, morbid obesity, or heart disease, says the Centers for Disease Control and Prevention (CDC).

This multicentre, randomized, double-blind phase 3 study results were presented on October 6, 2018. 

Xofluza (Baloxavir marboxil) was discovered and developed by Shionogi & Co., Ltd.   

“This is the first phase III trial to demonstrate a significant, clinically meaningful benefit in people at high-risk for complications from the flu for which there are no currently approved medicines,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development, in a press release.  

“This study adds to the growing body of evidence supporting Xofluza (baloxavir marboxil) as a potential first-in-class antiviral flu treatment.” 

The CAPSTONE-2 study also showed that baloxavir marboxil demonstrated efficacy in influenza type A/H3N2 (median time of 75.4 hours and 100.4 hours) and type B (median time of 74.6 hours and 100.6 hours) versus placebo. 

In addition, results for the overall patient population of the study showed numerically shorter time to the improvement of influenza symptoms of Xofluza (baloxavir marboxil) versus oseltamivir with a median time to the improvement of symptoms of 73.2 hours for baloxavir marboxil compared with 81.0 hours for oseltamivir, known commonly at Tamiflu. 

In the subpopulation of patients with influenza type B, a subgroup where some antiviral treatments have shown only limited efficacy or inconclusive data, Xofluza (baloxavir marboxil) was significantly more efficacious than oseltamivir in reducing the time to the improvement of symptoms (median time of 74.6 hours versus 101.6 hours). 

During June 2018, the Food and Drug Administration (FDA) accepted a New Drug Application (NDA) and granted Priority Review to baloxavir marboxil as a single-dose, oral treatment for acute, uncomplicated influenza in people 12 years and older based on the results from CAPSTONE-1 and an earlier phase II study. 

The FDA is expected to make a decision on approval by December 2018. 

If approved, Xofluza (baloxavir marboxil) will be the first single-dose oral antiviral, and the first medicine with a novel proposed mechanism of action to treat flu symptoms in nearly 20 years. 

Genentech, a member of the Roche Group, also announced that they have entered into a private-public partnership with the Biomedical Advanced Research and Development Authority (BARDA) of the US Department of Health and Human Services (HSS), to advance the development of medicines for infectious diseases for which there is a significant unmet need. As part of the agreement, BARDA will provide funding that will support the development of Xofluza (baloxavir marboxil) for severely ill hospitalized influenza patients, with the potential for funding of other studies.   

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. For more information, please visit www.roche.com.