Roche has secured approval from the US Food and Drug Administration (FDA) for its Xofluza (baloxavir marboxil) to treat acute, uncomplicated influenza, or flu in people aged 12 years and older.
Xofluza is a first-in-class and single-dose oral medicine with a novel proposed mechanism of action, which restricts polymerase acidic endonuclease, an enzyme required for viral replication.
According to the company, Xofluza has showed efficacy against a wide range of influenza viruses, including oseltamivir-resistant strains and avian strains, in non-clinical studies.
The approval was based on results from the phase III Capstone-1study of a single-dose of Xofluza compared with placebo or oseltamivir 75mg, twice daily for five days, and also results based on a placebo-controlled phase II study.
The drug is said to significantly reduce the duration of flu symptoms compared against placebo, and showed similar efficacy compared compared to oseltamivir in the studies.
Capstone-1 was a phase III multicentre, randomised, double-blind and placebo-controlled study, which assessed the efficacy and safety of Xofluza in 1,436 people aged 12 and older in the US and Japan.
The phase III Capstone-2 study evaluating the safety and efficacy of Xofluza in people at high risk of complications from the flu has achieved the primary objective and showed superior efficacy in the primary endpoint of time to improvement of influenza symptoms against placebo.
The drug will also be further assessed in a phase III development program, including pediatric populations, post-exposure prophylaxis and severely ill hospitalised people with influenza.
Discovered by Shionogi & Co, Xofluza is being further developed and commercialized in collaboration with the Roche across the globe.
As per terms of the deal, Roche has worldwide rights to Xofluza excluding Japan and Taiwan, which will be retained exclusively by Shionogi & Co.
In February this year, the Japanese Ministry of Health, Labor and Welfare approved the drug to treat influenza types A and B in adult and pediatric patients.
Roche chief medical officer and global product development head Dr Sandra Horning said: “Xofluza is the first new flu medicine with a novel proposed mechanism of action approved in nearly 20 years, and we’re excited to offer a convenient treatment option that reduces flu symptoms by more than a day with a single oral dose.
“If patients see their doctors within 48 hours of symptom onset, one dose of Xofluza can significantly reduce the duration of flu symptoms.”