Flu Rx Approval Expanded

Xofluza (baloxavir marboxil) approved in Europe

(RxWiki News) The approval of a common flu treatment just got expanded.

The European Commission approved Xofluza (baloxavir marboxil) to treat uncomplicated influenza infection in patients who are 12 years old or older. It was also approved to help prevent the flu in those who have been exposed to someone who was ill.

“Xofluza offers patients the first novel mechanism of action for treating influenza approved in Europe in almost 20 years,” said Dr. Levi Garraway, chief medical officer and head of Global Product Development for Roche, in a press release. “With approval for both treatment and post-exposure prophylaxis, we are hopeful Xofluza will help patients recover more quickly while also reducing the societal burden of influenza, especially amid the COVID-19 pandemic.”

Xofluza was first approved to treat the flu in the United States in 2018. More recently, in November of 2020, the US Food and Drug Administration (FDA) expanded the approval of Xofluza for use in the prevention of the flu in people who have been exposed to someone who had the illness.

Now, Xofluza has been approved for both uses in Europe — treating a flu infection and preventing the flu in those who have been exposed.

This approval was based on the data from three clinical trials of Xofluza. Two of these trials assessed how long the drug took to cause improvements in symptoms. Researchers compared baloxavir marboxil (Xofluza) with a placebo and another flu treatment (oseltamivir). In both trials, those treated with Xofluza showed improved symptoms nearly 30 hours sooner than those who did not receive this treatment.

The third trial studied Xofluza's effectiveness in preventing the flu in those who have been exposed to someone who had the flu. Compared to those who received a placebo, those who took Xofluza were 90 percent less likely to get the flu.

The flu vaccine is still widely available and is the most effective way to prevent the flu. If you are having flu symptoms or believe you might be at risk for catching the flu, ask your health care provider about the best flu treatment or prevention method for you.

Reviewed by: 
Review Date: 
February 22, 2021