Shionogi files Xofluza sNDA in Japan

Japanese drugmaker Shionogi (TYO: 4507) has filed a supplemental New Drug Application (sNDA) for Xofluza (baloxavir marboxil) in its native country for the postexposure prophylaxis of influenza virus infection.

The sNDA is based on data from the Phase III BLOCKSTONE study, which assessed Xofluza in the post-exposure prophylaxis of influenza virus infection in people who were household members of infected patients.

“The results from BLOCKSTONE show the potential of Xofluza as an important prophylactic treatment option for influenza,” said Tsutae Den Nagata, chief medical officer at Shionogi. “Therefore, if this indication is approved, we believe that Xofluza will help to reduce the burden of influenza in both the symptomatic and prophylactic treatment settings.”