OSAKA - Shionogi & Co., Ltd. (Head Office: Osaka, Japan; President and CEO: Isao Teshirogi, Ph.D.; hereafter 'Shionogi') today announced that its License Partner F. Hoffmann-La Roche Ltd. (Head Office: Basel, Switzerland; CEO: Severin Schwan, L.L.D.; hereafter 'Roche') which holds worldwide rights to Xofluza (baloxavir marboxil) excluding Japan and Taiwan, has received European Commission (EC) approval for Xofluza, 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 follows the positive opinion received from the Committee for Medicinal Products for Human Use (CHMP) on November, 2020, and is based on the results of the phase III CAPSTONE-1, CAPSTONE-2 and BLOCKSTONE studies.1, 2, 3 Xofluza is available in more than 30 countries for the treatment of influenza types A and B.

Shionogi is committed to 'protect people worldwide from the threat of infectious diseases' as our key focus. We are not limiting ourselves to the research and development of therapeutic medications, but are also focusing on the total care of infectious disease through awareness building, prevention, diagnosis and suppression of exacerbation. Shionogi will continue to work diligently to collect and analyze data on the efficacy and safety of Xofluza, and provide information for appropriate use.

About CAPSTONE-1 Study1

The CAPSTONE-1 study was a Phase III, randomized, double-blind, multicenter, parallel-group, placebo- and active-controlled study that enrolled 1,436 otherwise healthy patients diagnosed with influenza. In this study, Xofluza (baloxavir marboxil) significantly reduced the duration of influenza symptoms by more than a day compared with placebo (median time; 53.7 hours versus 80.2 hours; p

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