Roche’s Xofluza Secures EU Authorization
Roche’s new influenza treatment and preventative drug, Xofluza (baloxavir marboxil), has been approved by EU regulators.
The drug is indicated to treat uncomplicated influenza in patients age 12 and up or to prevent influenza in individuals following contact with someone infected with the virus. The approval was based on positive results from three phase 3 studies.
Xofluza is a “prodrug” that is metabolized in the body as an enzyme inhibitor that blocks the viral life cycle. Roche said the approval “marks the first innovation in mechanism of action for an influenza antiviral” approved by the European Commission in almost 20 years.