FDA News

FDA approves Xofluza for patients at high risk for flu-related complications

The FDA has approved Xofluza for the treatment of patients aged 12 years or older who are at high risk for developing influenza-related complications and have been symptomatic for no more than 2 days, Genentech announced.

The FDA first approved Xofluza (baloxavir marboxil) in October 2018 for the treatment of acute, uncomplicated influenza among patients aged 12 years or older. In March of this year, the agency accepted Genentech’s supplemental new drug application for baloxavir marboxil with an expanded indication for patients at high risk for influenza-related complications.

According to a news release, baloxavir marboxil was developed with a novel mechanism of action that inhibits polymerase acidic endonuclease. The first-in-class, one-dose oral drug was the first new influenza treatment approved by the FDA in nearly 20 years.

“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,” Levi Garraway, MD, PhD, chief medical officer and head of global product development at Genentech, said in the release.

The phase 3 CAPSTONE-2 study assessed a single dose of 40 mg or 80 mg of baloxavir marboxil against a twice-daily, 5-day course of 75 mg of oseltamivir and a placebo. The results supported the FDA approval.

Baloxavir marboxil provides a treatment option for people with chronic conditions, including asthma, heart disease and diabetes, who are at a higher risk for developing serious complications as a result of contracting influenza.

“It is critical that these patients speak with their health care providers about possible treatment at the first signs and symptoms of the disease,” Garraway said.

Disclosure: Garraway is employed by Genentech.

The FDA has approved Xofluza for the treatment of patients aged 12 years or older who are at high risk for developing influenza-related complications and have been symptomatic for no more than 2 days, Genentech announced.

The FDA first approved Xofluza (baloxavir marboxil) in October 2018 for the treatment of acute, uncomplicated influenza among patients aged 12 years or older. In March of this year, the agency accepted Genentech’s supplemental new drug application for baloxavir marboxil with an expanded indication for patients at high risk for influenza-related complications.

According to a news release, baloxavir marboxil was developed with a novel mechanism of action that inhibits polymerase acidic endonuclease. The first-in-class, one-dose oral drug was the first new influenza treatment approved by the FDA in nearly 20 years.

“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,” Levi Garraway, MD, PhD, chief medical officer and head of global product development at Genentech, said in the release.

The phase 3 CAPSTONE-2 study assessed a single dose of 40 mg or 80 mg of baloxavir marboxil against a twice-daily, 5-day course of 75 mg of oseltamivir and a placebo. The results supported the FDA approval.

Baloxavir marboxil provides a treatment option for people with chronic conditions, including asthma, heart disease and diabetes, who are at a higher risk for developing serious complications as a result of contracting influenza.

“It is critical that these patients speak with their health care providers about possible treatment at the first signs and symptoms of the disease,” Garraway said.

Disclosure: Garraway is employed by Genentech.