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
“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. 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. The WHO estimates that up to 72,000 people in the Europe region die prematurely due to causes associated with influenza each year. 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.
Xofluza is a first-in-class, single-dose oral medicine with an innovative mechanism of action that has demonstrated efficacy in a wide range of influenza viruses, including in vitro activity against oseltamivir-resistant strains and avian strains (H7N9, H5N1) in non-clinical studies. Xofluza is the first in a class of antivirals designed to inhibit the cap-dependent endonuclease protein, which is essential for viral replication.
Xofluza is available in more than 30 countries for the treatment of influenza types A and B. In the US, Xofluza is approved for the treatment of acute, uncomplicated influenza in patients aged 12 years and above who are otherwise-healthy or at high-risk of developing serious complications from influenza, and who have been symptomatic for no more than 48 hours. Xofluza is also approved for post-exposure prophylaxis of influenza in individuals 12 years of age and older. Xofluza was the first new antiviral to be approved by the FDA in 20 years, and is the first innovation in mechanism of action for an influenza antiviral approved by the EC in almost 20 years.
