Roche’s antiviral reduces symptoms in patients at high risk of complications from flu

Roche has revealed the results of its Phase III CAPSTONE-2 study in which its investigational oral, single-dose antiviral, baloxavir marboxil, has shown superior efficacy in the primary endpoint of time to improvement of flu symptoms versus placebo.

The study assessed the safety and efficacy of the treatment in patients at high-risk of complications from flu. As per the Centers for Disease Control and Prevention (CDC) definition, people at high risk for serious flu complications to include adults 65 years of age or older, or those who have conditions such as asthma, chronic lung disease, diabetes, or heart disease.

Not only did baloxavir marboxil meet the primary endpoints of the study but also demonstrated superior efficacy compared to placebo and oseltamivir for important secondary endpoints, including reducing the time that the virus continued to be released (viral shedding) and reducing viral levels in the body.

“Baloxavir marboxil is the first antiviral to show a clinically meaningful benefit in people who are most susceptible to complications from the flu, including older people and those living with certain medical conditions,” said Dr Sandra Horning, Roche’s chief medical officer and head of Global Product Development. “We plan to submit the results of this second positive phase III study for baloxavir marboxil to healthcare authorities, and look forward to discussing next steps since there are no current antiviral medicines approved to specifically treat this high-risk population.”

The therapy, which was found to have a significant benefit over placebo in otherwise healthy people in the Phase III CAPSTONE-1 study, received acceptance from the US FDA for its new drug application (NDA) and was granted priority review as a single-dose, oral treatment for acute, uncomplicated influenza in people 12 years and older based on the Phase II study. A decision on approval is expected to be made by 24 December 2018. If it receives approval it will be the first single-dose oral antiviral and the first medicine with a novel proposed mechanism of action to treat the flu in nearly 20 years.