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  • EU approves Xofluza for influenza in patients aged...

EU approves Xofluza for influenza in patients aged 12 years and above.- Roche

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Published:12th Jan 2021
Roche 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.CAPSTONE-1 was a phase III multicentre, randomised, double-blind, placebo-controlled study that evaluated the efficacy and safety of Xofluza (baloxavir marboxil) compared with placebo and oseltamivir in otherwise-healthy individuals with acute uncomplicated influenza, aged 12 and above in the US and Japan. The primary endpoint of the study was time to alleviation of symptoms. Xofluza significantly reduced the duration of influenza symptoms by more than one day compared with placebo (median time 53.7 hours versus 80.2 hours; p<0.001). similar efficacy results were seen between xofluza and oseltamivir in relation to time to alleviation of symptoms (median time 53.5 hours versus 53.8 hours). xofluza was well tolerated in this study and no new safety signals were identified. in capstone-2, the primary endpoint of the study was time to improvement of influenza symptoms. capstone-2 was the first prospective, controlled phase iii clinical trial to demonstrate a significant and clinically meaningful benefit from an antiviral medicine in people at high-risk of serious influenza complications (median time to improvement in symptoms 73.2 hours for xofluza, 102.3 hours for placebo, p><0.0001). similar median time to improvement in symptoms was seen between the xofluza and oseltamivir groups (73.2 hours vs 81.0 hours, respectively).>
Condition: Influenza
Type: drug

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