FDA News

FDA approves Xofluza as first new flu treatment in nearly 20 years

Photo of Scott Gottlieb
Scott Gottlieb

The FDA today approved Xofluza for the treatment of acute uncomplicated influenza in patients aged 12 years or older who have been symptomatic for up to 48 hours.

The single-dose oral medication — baloxavir marboxil (Genentech) — is the first new antiviral influenza treatment with a novel mechanism of action approved in almost 20 years, according to FDA Commissioner Scott Gottlieb, MD.

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

Genentech announced in June that the FDA had accepted a new drug application for baloxavir marboxil and granted it priority review based on phase 3 data from the CAPSTONE-1 trial that showed the treatment significantly reduced the duration of influenza symptoms by more than 1 day and was similarly effective compared with oseltamivir.

According to the Roche Group, which includes Genentech, baloxavir marboxil “has demonstrated efficacy against a wide range of influenza viruses, including oseltamivir-resistant strains and avian strains (H7N9, H5N1) in non-clinical studies.”

“If patients see their doctors within 48 hours of symptom onset, one dose of Xofluza can significantly reduce the duration of flu symptoms,” Sandra Horning, MD, chief medical officer and head of global product development at Roche, said in a news release.

Roche holds rights to baloxavir marboxil worldwide, excluding Japan and Taiwan, where they are held exclusively by Shionogi. The treatment, which was discovered by Shionogi, was approved in February in Japan for adult and pediatric patients with influenza types A and B.

Roche said another phase 3 study will explore baloxavir marboxil in pediatric patients, as post-exposure prophylaxis and in severely ill hospitalized patients with influenza and will also assess the treatment’s potential to reduce transmission in otherwise healthy people.

Disclosures: Gottlieb reports no relevant financial disclosures.

Photo of Scott Gottlieb
Scott Gottlieb

The FDA today approved Xofluza for the treatment of acute uncomplicated influenza in patients aged 12 years or older who have been symptomatic for up to 48 hours.

The single-dose oral medication — baloxavir marboxil (Genentech) — is the first new antiviral influenza treatment with a novel mechanism of action approved in almost 20 years, according to FDA Commissioner Scott Gottlieb, MD.

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

Genentech announced in June that the FDA had accepted a new drug application for baloxavir marboxil and granted it priority review based on phase 3 data from the CAPSTONE-1 trial that showed the treatment significantly reduced the duration of influenza symptoms by more than 1 day and was similarly effective compared with oseltamivir.

According to the Roche Group, which includes Genentech, baloxavir marboxil “has demonstrated efficacy against a wide range of influenza viruses, including oseltamivir-resistant strains and avian strains (H7N9, H5N1) in non-clinical studies.”

“If patients see their doctors within 48 hours of symptom onset, one dose of Xofluza can significantly reduce the duration of flu symptoms,” Sandra Horning, MD, chief medical officer and head of global product development at Roche, said in a news release.

Roche holds rights to baloxavir marboxil worldwide, excluding Japan and Taiwan, where they are held exclusively by Shionogi. The treatment, which was discovered by Shionogi, was approved in February in Japan for adult and pediatric patients with influenza types A and B.

Roche said another phase 3 study will explore baloxavir marboxil in pediatric patients, as post-exposure prophylaxis and in severely ill hospitalized patients with influenza and will also assess the treatment’s potential to reduce transmission in otherwise healthy people.

Disclosures: Gottlieb reports no relevant financial disclosures.