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
'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
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
(C) 2020 Electronic News Publishing, source