On Nov. 13, 2020, Roche announced that the European Medicines Agencyﾒs (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Xofluzaﾮ (baloxavir marboxil) for the treatment of uncomplicated influenza in patients aged 12 years and above.

In addition, Xofluza was recommended for approval as a preventive treatment (post-exposure prophylaxis) of influenza in individuals aged 12 years and above.