Basel, 13 November 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Xofluza® (baloxavir marboxil) for the treatment of uncomplicated influenza in patients aged 12 years and above. In addition, Xofluza has been recommended for approval as a preventive treatment (post-exposure prophylaxis) of influenza in individuals aged 12 years and above. The CHMP recommendation is based on the results of the phase III CAPSTONE-1, CAPSTONE-2 and BLOCKSTONE studies.1,2,3 A final decision regarding the approval is expected from the European Commission in the near future.

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Roche Holding AG published this content on 13 November 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 13 November 2020 16:04:06 UTC