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

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January 11, 2021 – Roche 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 in individuals aged 12 years and above. Post-exposure prophylaxis aims to prevent influenza in individuals following contact with someone infected with the influenza virus. This approval is based on the results of the phase III CAPSTONE-1, CAPSTONE-2 and BLOCKSTONE studies.

Influenza is one of the most common, yet serious, infectious diseases, representing a significant threat to public health. Globally, seasonal influenza epidemics result in three to five million cases of severe disease, millions of hospitalisations and up to 650,000 deaths every year.

“We are delighted that the European Commission has approved Xofluza, a first-in-class, single-dose oral medicine, for the treatment of influenza,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Xofluza offers patients the first novel mechanism of action for treating influenza approved in Europe in almost 20 years. With approval for both treatment and post-exposure prophylaxis, we are hopeful Xofluza will help patients recover more quickly while also reducing the societal burden of influenza, especially amid the COVID-19 pandemic.”