Investigational Antiviral Flu Drug Achieves Efficacy Goal in Phase 3 Trial

The phase 3 CAPSTONE-2 study of the safety and efficacy of baloxavir marboxil in patients at high risk of complications due to influenza (flu) has met the primary objective of efficacy of a single dose of baloxavir marboxil compared to placebo as measured by time to improvement of flu symptoms. The Centers for Disease Control and Prevention defines patients at high risk of complications from influenza as adults age 65 and older or those with conditions including asthma, chronic lung disease, diabetes, or heart disease.

Baloxavir marboxil additionally performed better compared to placebo and oseltamivir for secondary endpoints including reducing the time that the virus continued to be released (viral shedding) and reducing viral levels in the body. The drug also significantly reduced the incidence of flu-related complications compared to placebo.

"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 Sandra Horning, MD, Roche's Chief Medical Officer and Head of Global Product Development.

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