* One-dose, oral Xofluza has been recommended for approval for the treatment of uncomplicated influenza in patients aged 12 years and above

* Xofluza has also been recommended for approval as a preventive treatment (post-exposure prophylaxis) of influenza in individuals aged 12 years and above

* If approved, Xofluza would be the first innovation in mode of action for an influenza antiviral approved by the European Commission in almost 20 years

Basel - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Xofluza® (baloxavir marboxil) for the treatment of uncomplicated influenza in patients aged 12 years and above. In addition, Xofluza has been recommended for approval as a preventive treatment (post-exposure prophylaxis) of influenza in individuals aged 12 years and above. The CHMP recommendation is based on the results of the phase III CAPSTONE-1, CAPSTONE-2 and BLOCKSTONE studies.1,2,3 A final decision regarding the approval is expected from the European Commission in the near future.

"Today's CHMP recommendation brings patients with influenza one step closer to potentially benefiting from Xofluza's oral one-dose regimen, setting adults and adolescents on the path to feeling better sooner compared to placebo," said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. "We believe that access to effective antivirals for influenza, and particularly their use in the prophylactic setting, could help reduce the strain of the COVID-19 pandemic on healthcare systems in Europe."

Influenza is one of the most common, yet serious, infectious diseases, representing a significant threat to public health. Globally, seasonal epidemics result in three to five million cases of severe disease, millions of hospitalisations and up to 650,000 deaths every year.4,5,6 The WHO estimates that up to 72,000 people in the European region die prematurely due to causes associated with influenza each year.7 Antivirals, like Xofluza, are designed to target and treat the influenza virus.8,9,10

About CAPSTONE-11

CAPSTONE-1 was a phase III multicentre, randomised, double-blind, placebo-controlled study that evaluated the efficacy and safety of Xofluza® (baloxavir marboxil) in 1,436 individuals aged 12 and above in the US and Japan. The primary endpoint of the study was time to alleviation of symptoms. The study found the following results:

* Xofluza met its primary endpoint compared to placebo:

- Significantly reduced the duration of influenza symptoms by more than one day (median time 53.7 hours versus 80.2 hours; p

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