The study results demonstrated that Xofluza has reduced the time required to improve from flu symptoms compared to placebo
Image: Genentech's sprawling headquarters campus in South San Francisco. Photo: Courtesy of Coolcaesar at English Wikipedia.
Genentech, a company of Roche Group, has secured the US Food and Drug Administration (FDA) supplemental New Drug Application (sNDA) approval for Xofluza (baloxavir marboxil) for treating influenza.
Genentech Xofluza is indicated for acute, uncomplicated influenza or flu, in people of age 12 years and older, at high risk of developing flu-related complications.
Genentech global product development head and chief medical officer Levi Garraway said: “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.
“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 inhibits the enzyme polymerase acidic endonuclease
According to the company, influenza is capable of causing a variety of complications, varying from sinus, ear infections to more severe complications like pneumonia.
Xofluza is a single dose oral medicine, developed with an advance mechanism of action to inhibit the polymerase acidic endonuclease, a crucial enzyme in viral replication.
It has demonstrated efficacy in a variety of influenza viruses, including in vitro activity against oseltamivir-resistant strains and avian strains in previous non-clinical studies.
Genentech said that the FDA approval of the drug with expanded indication is based on results from the Phase III CAPSTONE-2 study of Xofluza in 40mg or 80mg doses compared to oseltamivir, or placebo in people aged 12 years or older, at high risk of flu complications.
The study results demonstrated that Xofluza has reduced the time required to improve from flu symptoms compared to placebo, in people infected with the flu type B virus.
Furthermore, the adverse events recorded in the study included diarrhoea, bronchitis, nausea, sinusitis and headache in adult and adolescent subjects.