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Perhaps hoping to add a powerful weapon against influenza before this flu season gains full steam, the FDA has waved through Roche’s antiviral Xofluza two months ahead of a decision deadline.
Xofluza, also known as baloxavir marboxil, is now “the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years,” FDA Commissioner Scott Gottlieb, M.D., said in a statement. For Roche’s Genentech, which gained ex-Japan/Taiwan rights from developer Shionogi in 2016, Xofluza is tasked with salvaging some big sales that generics to its popular flu drug Tamiflu have eaten up.
Though the FDA nod came two months ahead of schedule, Genentech said it would launch the drug across the U.S. in the coming weeks. It has set the drug’s wholesale acquisition cost at $150 and is also offering coupons that lower the...