Grey Approved Stamp

FDA Approves New Influenza Treatment

November 2, 2018

The FDA gave the go ahead for Shionogi and Roche’s Xofluza (baloxavir marboxil), a first-in-class, single-dose oral medicine for treating acute, uncomplicated influenza.

Xofluza’s novel proposed mechanism of action is the first approved in almost 20 years. In non-clinical studies it was shown to be effective against a wide range of influenza viruses, including oseltamivir-resistant strains and avian strains. Flu patients that take a single dose of Xofluza can see a significant reduction in the virus’ duration if they see their doctor within 48 hours of symptom onset.

The approval rides on results from Roche’s Phase III capstone study that compared one dose of Xofluza compared with oseltamivir 75 mg or a placebo. It was found to significantly reduce the length of flu symptoms compared to placebo, and showed efficacy similar to oseltamivir.

Xofluza was first discovered by Japanese drugmaker Shionogi and is currently being jointly developed and commercialized with the Roche Group. Roche holds worldwide rights to the drug, with the exception of Japan and Taiwan.

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