Legal status
Japan's Ministry of Health, Labour and Welfare and the US Food and Drug Administration (FDA) approved baloxavir marboxil based on evidence of its benefits and side effects from two clinical trials in adult and pediatric participants with uncomplicated influenza (Trial 1, 1518T0821 and Trial 2, NCT02954354[31]),[10] involving 1119 participants.[11][32] Both trials included clinical sites and participants in Japan, with Trial 2 adding clinical locations in the United States.[10][11]
Baloxavir marboxil was approved for sale in Japan in February 2018.[33] In October 2018, the FDA approved it for the treatment of acute uncomplicated influenza in people twelve years of age and older who have been symptomatic for no more than 48 hours.[5][34] The FDA application of baloxavir marboxil was granted priority review in the United States, and approval of Xofluza was granted to Shionogi & Co., Ltd. in October 2018.[5][34] Specifically, the FDA approved the use of baloxavir marboxil for people at high risk of developing influenza-related complications.[35] In October 2019, the FDA approved an updated indication for the treatment of acute, uncomplicated influenza in people twelve years of age and older at risk of influenza complications.[36]
Baloxavir marboxil was approved for medical use in Australia in February 2020.[1]
The safety and efficacy of baloxavir marboxil, an antiviral drug taken as a single oral dose, was demonstrated in two randomized controlled clinical trials of 1,832 subjects where participants were assigned to receive either baloxavir marboxil, a placebo, or another antiviral flu treatment within 48 hours of experiencing flu symptoms.[5] In both trials, subjects treated with baloxavir marboxil had a shorter time to alleviation of symptoms compared with subjects who took the placebo.[5] In the second trial, there was no difference in the time to alleviation of symptoms between subjects who received baloxavir marboxil and those who received the other flu treatment.[5]
The safety and efficacy of baloxavir marboxil for post-flu exposure prevention is supported by one randomized, double-blind, controlled trial in which 607 subjects, twelve years of age and older who were exposed to a person with influenza in their household, received either a single dose of baloxavir marboxil or a single dose of a placebo.[37] Of these 607 subjects, 303 received baloxavir marboxil and 304 received the placebo.[37] The trial's primary endpoint was the proportion of subjects who were infected with influenza virus and presented with fever and at least one respiratory symptom from day 1 to day 10.[37] Of those who received baloxavir marboxil, 1% of subjects met these criteria, compared to 13% of subjects who received a placebo for the clinical trial.[37]
Baloxavir marboxil was approved for medical use in the European Union in January 2021.[38]
