Roche claims that Xofluza is the first single-dose influenza medicine approved to prevent influenza for post-exposure prophylaxis
Roche’s Xofluza prevents influenza. (Credit: Myriams-Fotos from Pixabay.)
The US Food and Drug Administration (FDA) has approved Roche’s supplemental New Drug Application (sNDA) for Xofluza (baloxavir marboxil) to prevent influenza in people aged 12 years and above.
The US regulator approved Roche’s sNDA for Xofluza to treat adults and adolescents who came in contact with people who already had influenza, known as post-exposure prophylaxis.
The Swiss drugmaker said that its Xofluza is the first single-dose influenza medicine, approved for post-exposure prophylaxis.
Roche chief medical officer and global product development 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.”
Xofluza is a single-dose oral medicine that showed efficacy in a broad range of influenza viruses, and in-vitro activity against oseltamivir-resistant strains and avian strains including H7N9, H5N1, in non-clinical studies.
The drug is already approved in the US to treat acute uncomplicated influenza in children, aged 12 years and above, with influenza symptoms and who are at high risk of developing influenza-related complications.
Roche studied the single-dose Xofluza post-exposure prophylaxis in the Phase 3 BLOCKSTONE study, compared with placebo as a preventive treatment for members in a house, living with someone having influenza.
In the Phase 3 study, Xofluza showed a statistically significant prophylactic effect on influenza after a single oral dose was well tolerated with no new safety concerns reported.
Diarrhoea, bronchitis, nausea, sinusitis, and headache include the most frequently reported adverse events in the BLOCKSTONE clinical trial.
Furthermore, Roche intends to seek FDA approval for Xofluza to treat acute uncomplicated influenza in children aged 12 years, and prevent influenza in children exposed to influenza.
Families Fighting Flu chief operating officer Serese Marotta said: “The flu is a serious illness that burdens households and sickens millions across the US every year.
“As we are about to enter a flu season within a global Covid-19 pandemic, we welcome Xofluza as a single-dose flu medicine to be used preventively after exposure to flu.”