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

• The European Commission (EC) has approved single-dose, oral Xofluza for the treatment of uncomplicated influenza in patients aged 12 years and above
• The EC has also approved Xofluza for post-exposure prophylaxis of influenza in individuals aged 12 years and above
• Xofluza, with its rapid reduction in viral replication, could help patients recover more quickly, while also reducing the societal burden of influenza
  
  

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 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. 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

“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.”

Influenza is one of the most common, yet serious, infectious diseases, representing a significant threat to public health.^5,6 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.^7,8,9 The WHO estimates that up to 72,000 people in the Europe region die prematurely due to causes associated with influenza each year.¹⁰ Antivirals are the only effective treatment specifically designed to target and treat the influenza virus, and their use shows a significant and sustained reduction in the use of key healthcare resources, providing a relief on healthcare costs.^{11,12,13,14,15}