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Roche’s flu drug Xofluza scores phase 3 primary endpoint

Demonstrates efficacy as a preventative treatment


Roche has produced promising phase 3 data for its influenza drug Xofluza (baloxavir marboxil) as a preventative treatment for household members who are living with someone with a confirmed influenza infection. 

Xofluza, a single-dose, investigational oral medicine, has just achieved its primary endpoint of fewer people testing positive for flu, in the BLOCKSTONE study comparing it with placebo.

The drug was discovered and developed by Shionogi, and is already approved in Japan, with Roche holding the marketing rights outside Japan and Taiwan.

The BLOCKSTONE trial showed that when Xofluza was taken as a preventive treatment after exposure to an infected household member, it significantly reduced the risk of people developing flu by 86% compared to placebo. The trial also observed Xofluza in household members who are at high risk of flu-associated complications and children under 12 years of age.

Xofluza was approved by the FDA last year, and is available as a treatment for acute, uncomplicated influenza in people aged 12 years and older. It has already been shown to be effective against a wide range of flu viruses, including those resistant to Roche’s now off-patent and former blockbuster flu treatment, Tamiflu (oseltamivir).

Sandra Horning

Sandra Horning, Roche's chief medical officer

“As the influenza virus can rapidly infect those around us, limiting the spread of infection within households potentially avoids a significant impact on the wider community – a critical step in the global fight against flu,” said Sandra Horning, Roche’s chief medical officer.

“We are encouraged by the BLOCKSTONE study, the first to show that Xofluza is an effective preventive treatment following exposure to flu and we look forward to sharing this data with health authorities,” she added.

Roche is looking to further expand the use of Xofluza, with a New Drug Application under review by the FDA as a treatment for people at high risk of complications from flu, with a decision expected by November 2019.

In addition, Xofluza is currently being studied in a further phase 3 development programme, including children under the age of one and severely ill, hospitalised patients.

Roche is keen to produce more evidence of the significant benefits of the new treatment in order to convince healthcare systems to move away from generic oseltamivir. The Swiss pharma company is also in need of a new set of innovative products as its older generation of blockbusters come under competition from biosimilars.

When the FDA approved Xofluza last year, it stressed that the flu vaccination was the best way of fighting what is one of the most common, but potentially deadly infectious disease. However, the BLOCKSTONE trial and Roche’s further phase 3 studies are aiming to demonstrate the efficacy of its treatment as a preventative measure against flu as well as being an effective treatment of the virus when a patient is infected.

Article by
Lucy Parsons

2nd September 2019

From: Research



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