Image of a senior man recuperating in a hospital bed

The U.S. Food & Drug Administration has expanded approval of the oral antiviral drug baloxavir marboxil (Xofluza) for people at high risk of flu complications, according to the drug’s developer.

In a phase 3 clinical trial, baloxavir marboxil significantly reduced the time to improvement of flu symptoms in patients who fit the high-risk profile when compared to placebo.

Adults aged 65 and older are at high risk, as are people with conditions such as asthma, chronic lung disease, diabetes, heart disease, and morbid obesity, according to the Centers for Disease Control & Prevention.

The drug, in tablet form, is given as a one-time dose.

“With the flu season rapidly approaching, we can now offer Xofluza as the first and only FDA-approved treatment option indicated specifically for those at high risk of flu complications,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of global product development at Genentech.

The FDA originally approved the drug in October 2018 for uncomplicated patients over age 12.