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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



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