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Roche’s Xofluza issued FDA approval to treat influenza in children aged five years and older

It is the first and only single-dose oral medicine for this indication in children as young as five


Roche has received approval from the US Food and Drug Administration (FDA) for a supplemental New Drug Application (sNDA) for Xofluza (baloxavir marboxil). The approval is specifically 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.

In addition to this, the FDA has granted approval for Xofluza to be used as a preventative treatment of influenza in children aged five to less than 12 years old, following contact with someone who is infected with influenza.

The FDA’s decision makes Xofluza the first single-dose oral influenza medicine to be approved in the US for children in this age group.

The approval is supported by phase 3 trial results taken from miniSTONE-2 – which assessed the use of Xofluza in children – and BLOCKSTONE – which assessed Xofluza as a preventive treatment for households, in both adults and children. The results were published in The Pediatric Infectious Disease Journal and The New England Journal of Medicine, respectively.

There were more than six million illnesses, thousands of hospitalisations and over 100 deaths among children aged five to 17 caused by influenza in the US 2018-2019 influenza season.

miniSTONE-2 was a phase 3, multicentre, randomised, double-blind study that evaluated the safety, pharmacokinetics and effectiveness of a single-dose of Xofluza versus oseltamivir, in otherwise healthy children aged one to less than 12 years with influenza infection and displaying influenza symptoms for no more than 48 hours. The results showed that Xofluza was well tolerated with no new safety signals identified.

BLOCKSTONE was a phase 3, double-blind, multicentre, randomised, placebo-controlled, post-exposure prophylaxis study that evaluated single-dose Xofluza versus placebo in household members – adults and children – who were living with someone with influenza confirmed by a rapid influenza diagnostic test.

In the BLOCKSTONE trial, Xofluza showed a statistically significant preventative impact on influenza after a single dose, by reducing the risk of individuals aged 12 years and above from developing influenza after exposure to an infected household member by 90% versus placebo. The proportion of household members aged 12 years and above who developed laboratory-confirmed clinical influenza was 1.3% in participants treated with Xofluza and 13.2% in the placebo-treated group.

Levi Garraway, Roche’s chief medical officer and head of global product development, said: “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.”

Article by
Fleur Jeffries

12th August 2022

From: Research, Regulatory



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