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 3

The primary endpoint of the study was the rate of laboratory-confirmed clinical influenza during the ten day period after receiving treatment. Xofluza showed a statistically significant prophylactic effect on influenza after a single oral dose, by reducing the risk of individuals aged 12 years and above from developing influenza after exposure to an infected household member, by 90% versus placebo. The proportion of household members aged 12 years and above who developed laboratory-confirmed clinical influenza was 1.3% in participants treated with Xofluza and 13.2% in the placebo-treated group.

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

About Xofluza (baloxavir marboxil)
Xofluza is a first-in-class, single-dose oral medicine with an innovative mechanism of action that has demonstrated efficacy in a wide range of influenza viruses, including in vitro activity against oseltamivir-resistant strains and avian strains (H7N9, H5N1) in non-clinical studies.^16,17,18 Xofluza is the first in a class of antivirals designed to inhibit the cap-dependent endonuclease protein, which is essential for viral replication.^1,19

Xofluza is available in more than 30 countries for the treatment of influenza types A and B. In the US, Xofluza is approved for the treatment of acute, uncomplicated influenza in patients aged 12 years and above who are otherwise-healthy or at high-risk of developing serious complications from influenza, and who have been symptomatic for no more than 48 hours. Xofluza is also approved for post-exposure prophylaxis of influenza in individuals 12 years of age and older. Xofluza was the first new antiviral to be approved by the FDA in 20 years, and is the first innovation in mechanism of action for an influenza antiviral approved by the EC in almost 20 years.⁴

Robust clinical evidence has demonstrated the benefit of Xofluza in several populations (otherwise-healthy, high-risk and post-exposure prophylaxis in individuals aged 12 years and above). Xofluza is being further studied in a phase III development programme, including children under the age of one (NCT03653364) as well as to assess the potential to reduce transmission of influenza from an infected person to healthy people (NCT03969212).^1,2,3,20