BXM was developed for the market by Japanese pharmaceutical company Shionogi Co. and Switzerland-based Roche AG. The names of BXM and BXA appearing in the Shionogi research report are S-033188 and S-033447, respectively.
The Japanese Ministry of Health, Labour and Welfare (JMHLW) and the U.S. Food and Drug Administration (FDA) approved baloxavir marboxil based on evidence of benefit and side effects from two clinical trials in adults and children with uncomplicated influenza (Trial 1, 1518T0821 and Trial 2, NCT02954354), involved 1119 patients. Both trials included clinical sites and patients in Japan, with Trial 2 adding a clinical site in the United States.
As of September 2018, in the only report from a phase III randomized controlled trial, baloxavir reduced the duration of flu symptoms in otherwise healthy outpatients by approximately 1 day compared with placebo treatment, and was associated with Results of seltamivir treatment were quite group. On the first day after initiation of baloxavir, patients in the treatment group had a greater reduction in viral load than those in the oseltamivir or placebo groups; however, after five days, the effect of a single dose of baloxavir on viral load There was no difference from the effect observed after the full 5-day oseltamivir regimen in its treatment group.
Baloxavir marboxil was approved for sale in Japan in February 2018. In October 2018, the FDA approved it for the treatment of acute uncomplicated influenza for more than 48 hours in asymptomatic people 12 years and older. The FDA application for baloxavir marboxil was granted priority review in the United States, and Xofluza was approved by Shionogi & Co., Ltd. in October 2018. Specifically, the FDA approved baloxavir marboxil for people at high risk of developing flu-related complications. In October 2019, the FDA approved an updated indication for the treatment of acute uncomplicated influenza in people 12 years of age and older who are at risk for complications from influenza. In November 2020, the FDA approved an updated indication that includes influenza post-exposure prophylaxis for people 12 years of age and older following contact with someone with the flu.
Baloxavir marboxil was approved for medical use in Australia in February 2020.
Baloxavir marboxil is a single-dose oral antiviral drug whose safety and efficacy have been demonstrated in two randomized controlled clinical trials involving 1,832 subjects assigned to 48 Experience flu symptoms within hours of receiving baloxavir marboxil, placebo, or another antiviral flu treatment. In both trials, subjects who received baloxavir marboxil experienced shorter periods of symptom relief than subjects who received a placebo. In the second trial, subjects who received baloxavir marboxil and those who received other influenza treatments did not differ in the time to symptom relief.
The safety and efficacy of baloxavir marboxil in preventing post-influenza exposure is supported by a randomized, double-blind, controlled trial of 607 subjects aged 12 years and older who had home exposure to influenza patients received a single dose of baloxavir marboxil or a single dose of placebo. Of the 607 subjects, 303 received baloxavir marboxil and 304 received a placebo. The primary endpoint of the trial was the proportion of subjects who were infected with influenza virus and developed fever and at least one respiratory symptom from day 1 to day 10. 1% of subjects who received baloxavir marboxil met these criteria, compared with 13% of subjects who received placebo in clinical trials.
Baloxavir marboxil was approved for medical use in the European Union in January 2021.