The US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Roche’s Xofluza (baloxavir marboxil) as a treatment to prevent influenza in people aged 12 years and above following post-exposure prophylaxis.
Xofluza is the first single-dose influenza treatment approved for people who have come into contact with someone suffering from influenza.
It can potentially inhibit the cap-dependent endonuclease protein needed viral replication.
Roche Global Product Development chief medical officer and head Levi Garraway said: “With today’s approval, Xofluza is now available as the first single-dose, post-exposure preventive treatment for influenza.
“We’re hopeful that reducing the burden of influenza may help to mitigate the strain on our healthcare system amid the Covid-19 pandemic.”
A Phase III BLOCKSTONE study established the treatment’s prophylactic effect.
The phase III, double-blind, multicentre, randomised, placebo-controlled, post-exposure prophylaxis study evaluated single-dose of Xofluza compared with placebo in household members living with someone with influenza confirmed by a rapid diagnostic test.
Shionogi & Co conducted the study in Japan during the 2018-2019 influenza season.