Roche (SWX: ROG; OTCMKTS: RHHBY) has announced that its antiviral drug Xofluza (baloxavir marboxil) has received approval from the US Food and Drug Administration (FDA) based on positive results from the Phase III CENTERSTONE study. The study demonstrated that a single dose of Xofluza significantly reduced the transmission of influenza from infected individuals to household members, marking the first time an antiviral has shown such benefits in a global Phase III trial.
The CENTERSTONE trial was a global, multicenter, randomized, double-blind, and placebo-controlled study that included over 4,000 participants, aged 5 to 64 years, who had been diagnosed with influenza. The primary endpoint was the proportion of household contacts who tested positive for influenza within five days after the index patient was treated with either Xofluza or placebo. The results showed a significant reduction in the transmission of the virus with Xofluza, which was well-tolerated and had no new safety signals identified.
This approval is expected to bolster Roche’s position in the influenza treatment market and provide a new option for reducing the spread of the virus, especially during seasonal outbreaks and potential pandemics. The drug’s mechanism of action involves inhibiting the cap-dependent endonuclease protein, which is crucial for viral replication, potentially reducing the duration of infectiousness and disease severity.- Flcube.com
