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Genentech: CAPSTONE-2 Study With Baloxavir Marboxil For Flu Meets Primary Goal

Genentech, a member of the Roche Group (RHHBY), announced Tuesday that the Phase III CAPSTONE-2 study assessing the safety and efficacy of baloxavir marboxil in people at high risk of complications from the flu met the study's primary objective. The study showed superior efficacy in the primary endpoint of time to improvement of influenza symptoms versus placebo.

According to The Centers for Disease Control and Prevention or CDC, people at high risk for serious flu complications include adults 65 years of age or older, or those who have conditions such as asthma, chronic lung disease, diabetes or heart disease. For these people, the flu can lead to hospitalization or even death.

Baloxavir marboxil also demonstrated superior efficacy compared to placebo and oseltamivir for important secondary endpoints, including reducing the time that the virus continued to be released and reducing viral levels in the body.

Further, Baloxavir marboxil significantly reduced the incidence of influenza-related complications compared to placebo. It was well tolerated and no safety signals were identified.

The company said it will present the full results from the CAPSTONE-2 study at upcoming medical meetings.

Baloxavir marboxil was discovered and developed by Shionogi & Co., Ltd., and is sold in Japan under the trade name Xofluza.

Baloxavir marboxil has already demonstrated a clinically significant benefit over placebo in otherwise healthy people in the Phase III CAPSTONE-1 study.

The U.S. Food and Drug Administration recently accepted a New Drug Application or NDA and granted Priority Review to baloxavir marboxil as a single-dose, oral treatment for acute, uncomplicated influenza in people 12 years and older.

If approved, baloxavir marboxil would 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.

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