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Roche scores another FDA approval for Xofluza

Expands use to patients at high risk of flu-related complications

Roche

Roche’s Xofluza (baloxavir marboxil) has received FDA approval for use in people who have a high risk of developing influenza-related complications – expanding its reach even further. 

Roche received its first FDA approval for the drug last year, when it became the first new antiviral drug for nearly 20 years. Its first indication was for acute, uncomplicated influenza in people aged 12 or older.

It can now add that it is the first and only antiviral medicine indicated for high-risk patients, such as those who have conditions including asthma, chronic lung disease, diabetes, heart disease or morbid obesity or adults aged 65 or over.

This new approval is particularly important for Roche – it now has the evidence of benefits in high risk groups, which could help to encourage healthcare systems to switch away from generic oseltamivr.

The approval was based on results from Roche’s phase 3 CAPSTONE-2 trial of Xofluza, compared to oseltamivir or placebo, in people aged 12 or over, who met the criteria for being high risk of complications from flu.

It demonstrated that Xofluza significantly reduced the time of improvement of flu symptoms, including in people with flu type B virus.

However, similar efficacy results were seen between Xofluza and oseltamivir in relation to duration of symptoms (median time 73 hours versus 81 hours). This could cause difficulty in convincing healthcare systems to make the switch.

Adverse events were reported in at least 1% of adult and adolescent subjects treated with the drug, including diarrhoea (3%), bronchitis (3%), nausea (2%), sinusitis (2%) and headache (1%).

“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 Levi Garraway (pictured below), Roche’s chief medical officer and head of global product development.

Levi Garraway

Levi Garraway

“People with chronic conditions such as asthma, heart disease and diabetes are at higher risk of developing serious complications from 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,” he added.

The drug was initially discovered and developed by Shionogi, and is being developed and commercialised globally in collaboration with Roche Group. Roche holds worldwide rights to the drug, excluding Japan and Taiwan, which are retained exclusively by Shionogi.

Xofluza is also being studied in a further phase 3 development programme, including in children under the age of one, severely ill and hospitalised patients and to assess the potential to reduce transmission of flue from an infected person to health people.

Article by
Lucy Parsons

18th October 2019

From: Regulatory

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