Research & Development
Roche's Xofluza receives US FDA approval to treat influenza in children aged five years and older
15 August 2022 -

Switzerland based pharmaceutical company Roche (SIX: RO, ROG; OTCQX: RHHBY) announced on Friday that the United States Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Xofluza(R) (baloxavir marboxil) for the treatment of acute uncomplicated influenza in otherwise healthy children aged five to less than 12 years of age who have been symptomatic for no more than 48 hours.

This marks the first single-dose oral influenza medicine approved in the US for children in this age group. Additionally, the FDA approved Xofluza for the prevention (post-exposure prophylaxis) of influenza in children aged five to less than 12 years of age following contact with someone with influenza.

The FDA approval is based on results from two phase III studies: miniSTONE-2, which evaluated the use of Xofluza in children, and BLOCKSTONE, which evaluated Xofluza as a preventive treatment for household members, in both adults and children. The results from these studies were published in The Pediatric Infectious Disease Journal and The New England Journal of Medicine respectively.

'Despite the ongoing COVID-19 pandemic, influenza continues to be a threat to public health, and effective influenza antivirals remain critical to alleviating the burden on healthcare systems,' said Levi Garraway, M.D., Ph.D., Roche's chief medical officer and head of Global Product Development. 'Xofluza has proven to be an important tool in fighting and preventing influenza in adults as well as adolescents, and we are pleased to now offer households and younger children our single-dose oral treatment.'

Xofluza is already FDA-approved to treat 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. Xofluza is also approved to prevent influenza in people 12 years of age and older following contact with someone with influenza (known as post-exposure prophylaxis). Xofluza is available as a one-dose, single-tablet.

Login
Username:

Password:


Related Headlines