Please login to the form below

Not currently logged in
Email:
Password:

Roche’s Xofluza pill wins FDA approval for post-exposure flu prevention

First single-dose flu medication approved for post-exposure prophylaxis

Roche’s Xofluza pill has scored approval from the US Food and Drug Administration (FDA) for the prevention of flu in individuals who have had contact with an infected person.

Xofluza (baloxavir marboxil) is now indicated for use as a treatment to prevent influenza infection in people 12 years of age and above who have had contact with someone with influenza. This makes it the first single-dose flu med approved for post-exposure prophylaxis.

In the phase 3 BLOCKSTONE study, Xofluza achieved its primary endpoint of fewer people testing positive for flu when given as a post-exposure prophylaxis treatment.

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.

Xofluza was first 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).

“With today’s approval, Xofluza is now available as the first single-dose, post-exposure preventive treatment for influenza,” said Levi Garraway, chief medical officer and head of Global Product Development.

“We’re hopeful that reducing the burden of influenza may help to mitigate the strain on our healthcare system amid the COVID-19 pandemic,” he added.

Following the prevention approval, Roche is also aiming to move forward with potential indications for Xofluza as a treatment for uncomplicated influenza in otherwise healthy children aged one to 12 years.

The Swiss pharma is also eyeing regulatory approval for Xofluza as a preventative treatment for children in the same age group who have been exposed to flu.

“Flu is a serious illness that burdens households and sickens millions across the US every year,” said Serese Marotta, chief operating officer at Families Fighting Flu.

“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,” she added.

Article by
Lucy Parsons

25th November 2020

From: Regulatory

Share

Tags

PMEA Awards 2020

COVID-19 Updates and Daily News

Featured jobs

PMHub

Add my company
Nucleus Global

Nucleus Global is the largest specialist medical communications network in the world. Globally, we have over 800 experts delivering world-class...

Latest intelligence

EU health fund
An EU emergency health fund to limit the impact of future crises
Leading finance experts propose an Emergency Health Financing Facility to limit the impact of future crises on the EU...
Mistrust in medical research: a patient perspective
The recent development of several COVID-19 vaccines has placed medical research firmly in the spotlight, highlighting public confusion and misinformation about clinical trials. Patient advocate, Trishna Bharadia reveals what the...
Real-world evidence: breaking boundaries in rare disease
Generating data for drug launches is a challenging process. In rare diseases, with small patient populations and high unmet need, evidence generation is even more complex. Consultant Sarah Poole and...

Infographics