FDA greenlights Genentech’s Xofluza for acute, uncomplicated influenza
pharmafile | October 18, 2019 | News story | Medical Communications | FDA, Genetech, Roche, US, Xofluza, flu, pharma
Roche subsidiary Genentech has announced that its polymerase acidic endonuclease inhibitor Xofluza (baloxavir marboxil) has been awarded FDA approval in the treatment of acute, uncomplicated influenza.
The approval covers over the age of 12 who have been symptomatic for no more than 48 hours and who are at high risk of developing flu-related complications.
The US regulator’s discussion to approve the drug was supported by Phase 3 data showing that it “significantly reduced” the time to improvement of flu symptoms compared to placebo in patients over 12 who met the CDC criteria for being at high risk of flu complications, including those infected with the flu type B virus.
“With the 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 Dr Levi Garraway, Chief Medical Officer and head of Global Product Development. “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.”
Xofluza is now approved for both a & B flu types across a range of countries, including from the FDA in acute, uncomplicated flu in otherwise healthy people 12 years of age and older who have been symptomatic for no more than 48 hours, as of October last year.
Matt Fellows
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