Genentech’s Xofluza Approved for People at High Risk of Developing Flu-Related Complications


As the United States enters the cusp of the flu season, Genentech’s flu medication Xofluza won a new indication for the treatment of acute, uncomplicated influenza in people 12 years of age and older who have been symptomatic for less than 48 hours and are at high risk of flu-related complications.

The U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application for Xofluza (baloxavir marboxil) based on positive Phase III data from the CAPSTONE-2 study. The FDA hurried the new approval by a few weeks as it initially had a Nov. 4 PDUFA date. Xofluza first won approval in 2018 based on data from the CAPSTONE-1 study. In that clinical trial, Xofluza demonstrated a clinically significant benefit over placebo in otherwise healthy people with influenza. When Xofluza was approved, it was the first new flu treatment approved by the regulatory agency in two decades.

In the CAPSTONE-2 trial, Xofluza significantly reduced the time to improvement of flu symptoms compared to placebo, including in people infected with the flu type B virus.

Data shows that Xofluza posted a median time of 73 hours to significantly improve flu symptoms in comparison to placebo in people at high risk of complications from the flu. The U.S. Centers for Disease Control and Prevention (CDC) defines people at high risk of serious flu complications as those who have conditions such as asthma, chronic lung disease, diabetes, heart disease, morbid obesity or adults 65 years of age or older.

In trial subjects infected with type B virus, the median time to improvement of flu symptoms was shorter in the Xofluza group compared to the placebo group, 75 hours versus 101 hours respectively, Genentech said.

Xofluza has a novel mechanism of action that inhibits polymerase acidic endonuclease, an enzyme that is essential for the flu virus to replicate, according to Genentech.

In a brief statement, Levi Garraway, Roche’s new chief medical officer and head of global product development for the Swiss pharma giant, said Xofluza is now the first and only FDA-approved treatment indicated specifically for those at high risk of flu complications.

“People with chronic conditions such as asthma, heart disease and diabetes are at higher risk of developing serious complications from the flu, so it is critical that these patients speak with their healthcare providers about possible treatment at the first signs and symptoms of the disease,” said Garraway, who joined Genentech and parent company Roche in August following the retirement of CMO Sandra Horning.

Xofluza could be on its way to winning other approvals from the FDA. Last month, Genentech released trial data from the Phase III BLOCKSTONE study that showed an individual treated with Xofluza after being exposed to the flu by an infected household member, reduced the risk of developing the flu by 86% compared to placebo. Genentech said the preventative benefit of Xofluza remained statistically significant regardless of influenza A subtype. That preventative benefit was also seen in patients who are more susceptible to the flu due to pre-existing conditions and in children under the age of 12, Genentech said.

The flu represents a serious health threat each year. Globally, there are about 650,000 deaths from the flu worldwide and millions of people are hospitalized due to the illness.

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