Innovation Medical Specialties News

US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Roche’s Xofluza

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’s Xofluza gets FDA approval for influenza prevention

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.

Sandesh Ilhe
Sandesh Ilhe
With an Engineers degree in Advanced Database Management and Information Security, Sandesh brings the deep understanding of the digital world to the table. His articles reflect the challenges and the complexities that come along with every disruption in the industry. He carries over six years of experience on working with websites and ensuring that the right article reaches the right reader.