FDA approves first new flu drug in nearly 20 years

Food and Drug Administration

The first new influenza antiviral for almost two decades has been approved for use in the United States by its drugs safety watchdog.

Baloxavir marboxil (Xofluza; Roche) is being made available for the treatment of acute uncomplicated influenza in patients aged over 12 years who have had symptoms for up to 48 hours, following approval by the US Food and Drug Administration (FDA).

“This is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years,” said Scott Gottlieb, commissioner of the FDA.

“With thousands of people getting the flu every year, and many people becoming seriously ill, having safe and effective treatment alternatives is critical. This novel drug provides an important, additional treatment option.”

The FDA is still recommending immunisation as the first course of action but said that the new drug was effective in reducing influenza symptoms and length of illness if taken within 48 hours of becoming unwell.

The marketing approval for baloxavir marboxil follows the results of two randomised controlled clinical trials of 1,832 patients where participants received either baloxavir marboxil, a placebo, or another antiviral influenza treatment within 48 hours of experiencing flu symptoms.

In both trials, patients treated with baloxavir marboxil found their symptoms disappeared more quickly compared with patients who took the placebo. In the second trial, the pace of recovery was no different between those who received baloxavir marboxil and those who received the other influenza treatment.

Baloxavir marboxil was fast-tracked by the FDA and given priority review status on the grounds that it could “significantly improve the safety or effectiveness of treating, diagnosing or preventing a serious condition”.

Last updated
The Pharmaceutical Journal, FDA approves first new flu drug in nearly 20 years;Online:DOI:10.1211/PJ.2018.20205654

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