Roche's Xofluza Receives European Commission Approval for Influenza Treatment and Post-Exposure Prophylaxis
Roche
Oncology Drug Research, Development, and Manufacturing
European Commission
The European Commission, abbreviated as the EU Commission, is a supranational body under the European Union. Within the EU political system, the European Commission primarily undertakes executive tasks, thus being roughly equivalent to the government in a national system. However, the European Commission has other functions as well. In particular, except for the few circumstances specified in the treaties, the European Commission is the only institution with legislative power in the EU legislative process.
Compiled by Keke
On January 11, Roche announced that the European Commission (EC) had approved Xofluza® (baloxavir marboxil) for the treatment of uncomplicated influenza in patients aged 12 years and older. Furthermore, the European Commission has approved Xofluza for post-exposure prophylaxis of influenza in individuals aged 12 years and older. The purpose of post-exposure prophylaxis is to prevent influenza infection in individuals following contact with persons infected with the influenza virus.
The European Commission’s decision followed the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in November 2020 and was based on the results of three Phase 3 clinical studies: CAPSTONE-1, CAPSTONE-2, and BLOCKSTONE. This also marks the first innovation in the mechanism of action among influenza antiviral drugs approved in the European Community in nearly two decades.
Roche introduced CAPSTONE-1 as a Phase 3, multicenter, randomized, double-blind, placebo-controlled study that evaluated the efficacy and safety of Xofluza compared with placebo and oseltamivir in healthy individuals aged 12 years and older with acute uncomplicated influenza in the United States and Japan. The primary endpoint of the study was time to alleviation of symptoms.
The results showed that, compared with placebo, Xofluza significantly shortened the duration of influenza symptoms by more than one day (median time: 53.7 hours vs. 80.2 hours; p<0.001). In terms of time to symptom alleviation, Xofluza and oseltamivir demonstrated similar efficacy (median time: 53.5 hours vs. 53.8 hours). Furthermore, Xofluza was well tolerated in the CAPSTONE-1 study, with no new safety signals identified. This study was conducted by Shionogi & Co., Ltd. in the United States and Japan.
CAPSTONE-2 is a Phase 3, multicenter, randomized, double-blind study evaluating the efficacy and safety of a single dose of Xofluza compared with placebo and oseltamivir in individuals aged 12 to 64 years who are at high risk for influenza complications. The U.S. Centers for Disease Control and Prevention (CDC) defines populations at high risk for severe influenza complications as adults aged 65 years or older, or individuals with underlying medical conditions such as asthma, chronic lung disease, morbid obesity, or heart disease. The primary endpoint of the study was time to improvement in influenza symptoms.
Data indicate that CAPSTONE-2 is the first prospective, controlled Phase 3 clinical trial to demonstrate the significant clinical benefit of an antiviral drug in individuals at high risk for serious influenza complications. The median time to symptom improvement was 73.2 hours with Xofluza versus 102.3 hours with placebo (p<0.0001). Meanwhile, the median time to symptom improvement was similar between the Xofluza and oseltamivir groups (73.2 hours and 81.0 hours, respectively). Furthermore, Xofluza was well tolerated in this study, with no new safety signals identified. This study was conducted globally by Shionogi.
BLOCKSTONE was a Phase 3, double-blind, multicenter, randomized, placebo-controlled, post-exposure prophylaxis study that evaluated the efficacy of a single dose of Xofluza versus placebo in household contacts (adults and children) living with patients with influenza confirmed by rapid influenza diagnostic tests (i.e., index cases). The primary endpoint was the incidence of laboratory-confirmed clinical influenza within 10 days after treatment.
The results demonstrated that, compared with placebo, a single oral dose of Xofluza had a significant prophylactic effect against influenza, reducing the risk of developing influenza by 90% among individuals aged 12 years and older after exposure to infected household members. The proportion of household members aged 12 years and older with laboratory-confirmed clinical influenza was 1.3% in subjects treated with Xofluza, compared with 13.2% in the placebo group. Furthermore, Xofluza was well tolerated in the study, with no new safety signals identified. This study was conducted by Shionogi in Japan.
In the United States, Xofluza is approved for the treatment of acute, uncomplicated influenza in patients aged 12 years and older who are otherwise healthy or at high risk of developing serious complications from influenza, provided that symptoms have been present for no more than 48 hours. It is also approved for post-exposure prophylaxis of influenza in individuals aged 12 years and older. Currently, Xofluza is undergoing further investigation in a Phase 3 development program, including trials in infants under 1 year of age (NCT03653364) and studies evaluating its potential to reduce the transmission of influenza from infected individuals to healthy contacts (NCT03969212).
Reference source: Roche’s Xofluza approved by the European Commission for the treatment of influenza, the first new influenza antiviral for patients in almost 20 years
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