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Roche gets expanded approval for 'Xofluza' in the US

By Josh White

Date: Friday 18 Oct 2019

Roche gets expanded approval for 'Xofluza' in the US

(Sharecast News) - Roche announced on Friday that the US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for 'Xofluza; (baloxavir marboxil), for the treatment of acute, uncomplicated influenza - or flu - in people 12 years of age and older, who have been symptomatic for no more than 48 hours and who are at high risk of developing flu-related complications.
The Swiss pharmaceuticals giant described Xofluza as a first-in-class, one-dose oral medicine, with a novel proposed mechanism of action that inhibited polymerase acidic endonuclease - an enzyme essential for viral replication.

"With flu season rapidly approaching, we can now offer Xofluza as the first and only FDA-approved treatment option indicated specifically for those at high risk of flu complications," said Roche's chief medical officer and head of global product development, Levi Garraway.

"People with chronic conditions such as asthma, heart disease and diabetes are at higher risk of developing serious complications from the flu, so it is critical that these patients speak with their healthcare providers about possible treatment at the first signs and symptoms of the disease."

The company said the flu had the potential to cause a variety of complications, ranging from sinus or ear infections to more serious complications such as pneumonia.

It explained that the expanded indication for Xofluza was approved based on results from the phase 3 'CAPSTONE-2' study of a single dose of 40mg or 80mg of Xofluza, compared to oseltamivir at 75mg twice daily for five days, or placebo in people 12 years of age or older who met CDC criteria for being at high risk of complications from flu.

Xofluza reportedly significantly reduced the time to improvement of flu symptoms compared to placebo, including in people infected with the flu type B virus.

Adverse events reported in at least 1% of adult and adolescent subjects treated with Xofluza included diarrhoea, bronchitis, nausea, sinusitis and headache, Roche said.

The board added that Xofluza was currently approved in several countries for the treatment of influenza types A and B.

In October 2018, it was first approved by the FDA for the treatment of acute, uncomplicated flu in otherwise healthy people 12 years of age and older who had been symptomatic for no more than 48 hours, representing the first new antiviral to treat influenza in the United States in 20 years.

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