FDA News

FDA accepts supplemental NDA for Xofluza in high-risk patients with flu

The FDA has accepted a supplemental new drug application for Xofluza to treat patients at high-risk for complications from influenza, Genentech announced today. The company said a decision is expected by Nov. 4.

The FDA previously approved Xofluza (baloxavir marboxil) in October for the treatment of acute uncomplicated influenza in patients aged 12 years or older who have been symptomatic for at least 2 days. It was the first time in almost 20 years that an antiviral influenza treatment with a novel mechanism of action was approved in the United States.

According to Genentech, the supplemental NDA was based on data from the phase 3 CAPSTONE-2 study comparing a single oral dose of baloxavir marboxil with placebo or oseltamivir 75 mg, twice daily for 5 days, in patients aged 12 year or older at high risk for influenza complications.

In December, new guidelines issued by the Infectious Diseases Society of America emphasized the need to test and promptly treat such patients.

“Influenza ... can be especially debilitating for people considered to be high risk, as they have an increased likelihood of serious complications, worsening of existing health problems and even hospitalization or death,” Sandra Horning, MD, chief medical officer and head of global product development for Genentech, said in a news release. “Xofluza is the first antiviral medicine to demonstrate a significant and clinically meaningful benefit in people at high risk of complications from the flu, for which there are currently no approved medicines.”

CAPSTONE-2 included 2,184 patients at high risk for influenza-related complications who were randomly assigned in a 1:1:1 ratio to receive either baloxavir marboxil, placebo or oseltamivir. Results were presented at IDWeek in October.

In addition to other findings, the study showed that the treatment is well tolerated, significantly reduces the time to recovery from influenza symptoms compared with placebo (73.2 hours vs. 102.3 hours) and significantly reduces the median time to improvement of symptoms from influenza B infection compared with both placebo and oseltamivir (74.6 hours vs. 100.6 hours and 101.6 hours, respectively), according to Genentech. It also was superior to oseltamivir in shortening the duration of viral shedding.

The FDA has accepted a supplemental new drug application for Xofluza to treat patients at high-risk for complications from influenza, Genentech announced today. The company said a decision is expected by Nov. 4.

The FDA previously approved Xofluza (baloxavir marboxil) in October for the treatment of acute uncomplicated influenza in patients aged 12 years or older who have been symptomatic for at least 2 days. It was the first time in almost 20 years that an antiviral influenza treatment with a novel mechanism of action was approved in the United States.

According to Genentech, the supplemental NDA was based on data from the phase 3 CAPSTONE-2 study comparing a single oral dose of baloxavir marboxil with placebo or oseltamivir 75 mg, twice daily for 5 days, in patients aged 12 year or older at high risk for influenza complications.

In December, new guidelines issued by the Infectious Diseases Society of America emphasized the need to test and promptly treat such patients.

“Influenza ... can be especially debilitating for people considered to be high risk, as they have an increased likelihood of serious complications, worsening of existing health problems and even hospitalization or death,” Sandra Horning, MD, chief medical officer and head of global product development for Genentech, said in a news release. “Xofluza is the first antiviral medicine to demonstrate a significant and clinically meaningful benefit in people at high risk of complications from the flu, for which there are currently no approved medicines.”

CAPSTONE-2 included 2,184 patients at high risk for influenza-related complications who were randomly assigned in a 1:1:1 ratio to receive either baloxavir marboxil, placebo or oseltamivir. Results were presented at IDWeek in October.

In addition to other findings, the study showed that the treatment is well tolerated, significantly reduces the time to recovery from influenza symptoms compared with placebo (73.2 hours vs. 102.3 hours) and significantly reduces the median time to improvement of symptoms from influenza B infection compared with both placebo and oseltamivir (74.6 hours vs. 100.6 hours and 101.6 hours, respectively), according to Genentech. It also was superior to oseltamivir in shortening the duration of viral shedding.