Roche has announced positive topline data from the Phase III CENTERSTONE clinical trial of Xofluza (baloxavir marboxil), an antiviral treatment for influenza infection.

A single-dose oral treatment, Xofluza is designed to hinder viral replication by stopping the cap-dependent endonuclease protein, to lower the infectiousness and disease duration.

The US Food and Drug Administration (FDA) has approved Genentech’s supplemental new drug application (sNDA) for xofluza (baloxavir marboxil) to treat influenza in children.

The FDA has approved a new use for Xofluza (baloxavir marboxil) from Roche’s Genentech unit, to prevent people developing flu after coming into contact with an infectious person.

Roche announced that the US Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) as well as two supplemental New Drug Applications (sNDA) for Xofluza (baloxavir marboxil).

Xofluza from Roche’s Genentech unit was approved by the FDA for patients over the age of 12, and the company is hoping the label will be expanded to include children. But a new study out of the University of Wisconsin found that the flu virus can develop mutations that confer resistance to Xofluza—and that the problem occurs most frequently in children.

In 2018, Shionogi rolled out Xofluza in Japan as a one-dose kill for influenza, with Roche following suit in the US. Soon, though, Japanese regulators noticed the drug was leading to resistant flu strains, and now a new study in Nature confirms the drug leads to specific mutations that may hamper its promise to neutralize the virus in a single dose.

The FDA has approved the company’s supplemental new drug application (sNDA) for Xofluza to treat acute, uncomplicated influenza, or flu, in people 12 years of age and older

Roche’s new influenza drug Xofluza can dramatically prevent the spread of the virus when used as a preventive therapy, according to new phase 3 data.

Roche set out to make a better flu medicine than Tamiflu as that franchise was headed to a generic showdown. Now they’ll see just how well Xofluza stacks up against the mainstay drug after handing off over-the-counter rights in the US to Sanofi.

Roche’s flu drug Xofluza (baloxavir marboxil) has achieved primary endpoint in phase III Ministone-2 children study.