The FDA has approved the company’s supplemental new drug application (sNDA) for Xofluza to treat 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.
Xofluza is a first-in-class and one-dose oral medicine with a novel proposed mechanism of action that blocks polymerase acidic endonuclease, an enzyme crucial for viral replication.
Xofluza is claimed to be the first in a new class of antivirals designed to block the cap-dependent endonuclease protein.
Xofluza, which was discovered by Shionogi & Co., is being further developed and commercialised across the globe in collaboration with the Roche.
Xofluza’s expanded indication was approved based on data from the phase III CAPSTONE-2 study of a single dose of 40mg or 80mg of Xofluza compared against oseltamivir (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.
CAPSTONE-2 multicentre, randomised and double-blind study assessed a single dose of Xofluza against placebo and oseltamivir in people 12 years of age or older who are at a high risk of complications from flu.
At present, Xofluza was approved in various countries to treat influenza types A and B. In October 2018, Xofluza secured FDA approval to treat acute, uncomplicated flu in otherwise healthy people 12 years of age and older who have been symptomatic for no more than 48 hours.
Roche chief medical officer and global product development head Dr Levi Garraway said: “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.
“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.”
In September this year, Roche has secured FDA approval for its Rituxan (rituximab), in combination with glucocorticoids, to treat granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in paediatric patients two years of age and older.