Roche’s Xofluza approved by the European Commission for the treatment of influenza, the first new influenza antiviral for patients in almost 20 years - Seite 2

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) 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. The study was conducted in the US and Japan by Shionogi & Co., Ltd.

About CAPSTONE-2²
CAPSTONE-2 was a phase III, multicentre, randomised, double-blind study that evaluated the efficacy and safety of single-dose of Xofluza (baloxavir marboxil) compared with placebo and oseltamivir in individuals aged between 12 and 64 years, who were at high-risk of complications from influenza. The Centers for Disease Control and Prevention (CDC) defines people at high-risk for serious influenza complications to include adults 65 years of age or older, or those who have conditions such as asthma, chronic lung disease, morbid obesity, or heart disease.

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).

Xofluza was well tolerated in this study and no new safety signals were identified. The study was conducted globally by Shionogi & Co., Ltd.

About BLOCKSTONE³
BLOCKSTONE was a phase III, double-blind, multicentre, randomised, placebo-controlled, post-exposure prophylaxis study that evaluated single-dose of Xofluza (baloxavir marboxil) compared with placebo in household members (adults and children) who were living with someone with influenza confirmed by a rapid influenza diagnostic test (the ‘index patient’).