FDA approval of Xofluza (baloxavir marboxil) for influenza

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has approved Xofluza™ (baloxavir marboxil) for the treatment of acute, uncomplicated influenza, or flu, in people 12 years of age and older. Xofluza is a first-in-class, single-dose oral medicine with a novel proposed mechanism of action that inhibits polymerase acidic endonuclease, an enzyme essential for viral replication. Xofluza has demonstrated efficacy against a wide range of influenza viruses, including oseltamivir-resistant strains and avian strains (H7N9, H5N1) in non-clinical studies.

“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,” said Sandra Horning, MD, Roche's Chief Medical Officer and Head of Global Product Development. “If patients see their doctors within 48 hours of symptom onset, one dose of Xofluza can significantly reduce the duration of flu symptoms”.

The flu is one of the most common, yet serious, infectious diseases, representing a significant threat to public health. Globally, annual epidemics result in 3 to 5 million cases of severe disease, millions of hospitalisations and up to 650,000 deaths worldwide.

Xofluza was approved based on results from the phase III CAPSTONE-1 study of a single-dose of Xofluza compared with placebo or oseltamivir 75 mg, twice daily for five days, in otherwise healthy people with the flu, as well as results from a placebo-controlled phase II study in otherwise healthy people with the flu. Xofluza significantly reduced the duration of flu symptoms compared to placebo, and demonstrated similar efficacy compared to oseltamivir. In clinical trials, Xofluza was safe and well-tolerated with a side effect profile similar to placebo. The CAPSTONE-1 and phase II study results were recently published in the 6 September 2018 issue of the New England Journal of Medicine.

baloxavir marboxil, Xofluza, influenza, Roche