Roche has secured US FDA approval for its supplemental new drug application (sNDA) for Xofluza (baloxavir marboxil), an oral medicine, to prevent influenza in people 12 years and older following their contact with someone suffering with influenza or post-exposure prophylaxis.
Xofluza, a first-in-class and single-dose medicine, has showed efficacy in a range of influenza viruses, including in vitro activity against oseltamivir-resistant strains and avian strains (H7N9, H5N1) in non-clinical studies.
Xofluza is claimed to be the first single-dose influenza medicine that secured approval for post-exposure prophylaxis.
Roche has assessed post-exposure prophylaxis with single-dose Xofluza in the phase III Blockstone study.
The double-blind, multicentre, randomised, placebo-controlled, post-exposure prophylaxis study assessed a single dose of Xofluza compared with placebo in household members who have been living with someone suffering with influenza that was confirmed by a rapid influenza diagnostic test.
According to the company, Xofluza demonstrated a statistically significant prophylactic effect on influenza after a single oral dose in people exposed to an infected household contact.
Shionogin & Co, which discovered Xofluza, conducted the study in Japan during the 2018-2019 influenza season. Roche has collaborated with Shionogi to further develop and commercialise Xofluza across the globe.
Under the deal, Roche has worldwide rights to Xofluza excluding Japan and Taiwan, where Shionogi will exclusively have the rights.
Earlier, Xofluza had secured FDA approval to treat acute uncomplicated influenza in people 12 years of age and older who have had influenza symptoms for no more than 48 hours and who are otherwise healthy or at high risk of developing influenza-related complications.
Roche global product development head and chief medical officer Dr 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.”
In July this year, Roche announced that its Actemra/RoActemra (tocilizumab) has failed to achieve the primary endpoint in the phase III trial, which included hospitalised patients with severe Covid-19 associated pneumonia.