The US Food and Drug Administration (FDA) has approved baloxavir marboxil tablets (Xofluza, Shionogi) for the treatment of acute uncomplicated influenza in people age 12 years and older who have been symptomatic for no more than 48 hours.
"This is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years. With thousands of people getting the flu every year, and many people becoming seriously ill, having safe and effective treatment alternatives is critical. This novel drug provides an important, additional treatment option," FDA Commissioner Scott Gottlieb, MD, said in a news release.
Unlike neuraminidase inhibitors, such as oseltamivir (Tamiflu, Genentech), which inhibit the action of neuraminidase (an enzyme that frees viruses from the infected cells' surface), baloxavir marboxil prevents replication by inhibiting cap-dependent endonuclease activity of the viral polymerase./.../
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