FDA OKs baloxavir marboxil as postexposure prophylaxis for flu
Click Here to Manage Email Alerts
The FDA has expanded the approval of baloxavir marboxil to include postexposure prophylaxis for influenza in patients aged 12 years or older who have had contact with an infected person.
The expanded indication “will provide an important option to help prevent influenza just in time for a flu season that is anticipated to be unlike any other because it will coincide with the coronavirus pandemic,” Debra Birnkrant, MD, who heads the FDA’s Division of Antiviral Products, said in a press release.
The approval was supported by a randomized, double-blind, placebo-controlled trial conducted at dozens of primary care clinics in Japan that showed that household contacts of people with influenza were 86% less likely to develop influenza after receiving a single dose of baloxavir marboxil as postexposure prophylaxis.
The FDA originally approved the antiviral in 2018 to treat uncomplicated influenza — the first new influenza treatment in nearly 20 years. It is also approved to treat patients at high risk for influenza-related complications.
Influenza activity remains lower than usual in the United States for this time of year, according to CDC tracking. Moreover, previous data demonstrated that interventions to prevent COVID-19 have led to a global decline of influenza, including historically low levels of infection in the Southern Hemisphere.
But experts have also expressed concern that influenza season coinciding with a rise in COVID-19 cases could create a “perfect storm” for a U.S. health care system ill equipped to handle large surges of patients. Many adults have said they will forgo an influenza vaccine this year despite fears of an influenza-COVID-19 “twindemic.”
“Americans will have to be more vigilant than ever as these viruses spread concurrently,” Birnkrant said.
Collapse
Read more about
Click Here to Manage Email Alerts