Roche's Xofluza wins European approval for treating/preventing flu

Roche Holding AG received approval from the European Commission for Xofluza to treat uncomplicated influenza in patients aged 12 years and above.

The regulator also approved Xofluza, or baloxavir marboxil, for post-exposure prevention of the flu in individuals aged 12 years and above.

The approval follows a recommendation by the European Medicines Agency's Committee for Medicinal Products for Human Use in November 2020. The clearance is based on data from late-stage clinical trials Capstone-1, Capstone-2 and Blockstone, which showed the antiviral drug was effective in preventing the flu.

Worldwide, seasonal influenza epidemics result in up to five million cases of severe disease, millions of hospitalizations and up to 650,000 deaths annually. The World Health Organization estimates that up to 72,000 people in Europe die prematurely due to causes associated with the flu each year.

Xofluza was discovered by Japan's Shionogi & Co. Ltd. and is being further developed and commercialized globally in collaboration with the Roche and Shionogi. Basel, Switzerland-based Roche holds global rights to Xofluza excluding Japan and Taiwan, which will be retained by Shionogi.

In November 2020, the U.S. Food and Drug Administration approved Xofluza to prevent post-exposure flu in patients aged 12 years and older.