Europe Approves Xofluza, Roche's Revolutionary Influenza Antiviral with New Mechanism

The European Commission has approved Roche Holdings AG's RHHBY Xofluza (baloxavir marboxil) in children aged one year and above for uncomplicated influenza and post-exposure prophylaxis of influenza.
Post-exposure prophylaxis aims to prevent influenza in individuals following contact with someone infected with the influenza virus. The approval is based on the results of the phase 3 miniSTONE-2 and BLOCKSTONE studies.
The miniSTONE-2 study met its primary endpoint of safety and showed that Xofluza reduced the length of time that influenza was released from the body by more than two days compared with oseltamivir (viral replication; median time of 24.2 hours versus 75.8 hours, respectively).
In the BLOCKSTONE study, Xofluza showed a statistically significant prophylactic effect after a single oral dose by reducing the risk of people developing influenza after exposure to an infected household member by 86% versus placebo.
This approval marks the first single-dose, oral influenza medicine approved in Europe for children. Xofluza is the first innovation in the mechanism of action for influenza antiviral approved by the European Commission in almost 20 years.