Roche obtains EC approval of oral medicine Xofluza® to treat influenza

Roche, a Swiss pharmaceutical company, has recently announced the approval of Xofluza® (baloxavir marboxil) by the EC (European Commission) to treat uncomplicated influenza. This marks the 1st innovation in the mechanism of action for influenza antiviral approved by the commission in over 20 years.

Additionally, the EC has approved the medicine for the post-exposure prophylaxis of influenza among patients of 12 years and above. The latest decision happened along the heels of the positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency in November 2020, which is based on the clinical results of the CAPSTONE-1, CAPSTONE-2, & BLOCKSTONE trials. These three trials are Phase 3 multicenter, double-blind, randomized, placebo-controlled studies that examined Xofluza®’s safety and efficacy. The primary endpoints of the studies were time to alleviation of influenza symptoms, time to improvement of symptoms, and the rate of laboratory-confirmed clinical influenza respectively during 10 days after treatment.

Xofluza is a single-dose, first-in-class oral medicine that has high efficacy against a range of influenza viruses such as oseltamivir-resistant and avian strains in the non-clinical trials. The medicine is currently available in above 30 countries to treat two main types of influenza virus: A and B. It was discovered by Shionogi & Co., Ltd. and has been further developed and commercialized across the globe in collaboration with the Roche Group.

According to Levi Garraway, M.D., Ph.D., Chief Medical Officer & Head of Global Product Development at Roche, the company has shown excitement towards the recent approval for the treatment as well as post-exposure prophylaxis of influenza. This approval is also expected to reduce the societal burden of the disease, especially amid the ongoing COVID-19 pandemic.

Seasonal flu epidemics result in 3-5 million cases of severe disease, over 650,000 deaths, and millions of hospitalizations in a year worldwide. According to the WHO estimates, over 72,000 European people die prematurely due to cases related to influenza every year.

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