Roche ’s Xofluza approved by the European Commission for the treatment of influenza, the first new influenza antiviral for patients in almost 20 years

Basel, 11 January 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission (EC) has approved Xofluza® (baloxavir marboxil) for the treatment of uncomplicated influenza in patients aged 12 years and above. In addition, the EC has approved Xofluza for post-exposure prophylaxis of influenza i n individuals aged 12 years and above. Post-exposure prophylaxis aims to prevent influenza in individuals following contact with someone infected with the influenza virus. The Commission’s Decision follows the positive opinion received from the European Medicines Agency’s Committee for Medicinal Products for Human Use in November, 2020, and is based on the results of the phase III CAPSTONE-1, CAPSTONE-2 and BLOCKSTONE studies.1,2,3 This marks the first innovation in mechanism of action for an influenza antiviral approved by the EC in almost 20 years.4
Source: Roche Investor Update - Category: Pharmaceuticals Source Type: news