The FDA granted priority review to Roche for baloxavir marboxil, their single-dose, oral treatment of uncomplicated influenza. The agency is expected to make a final decision by the end of December.
Baloxavir marboxil, which is being developed by Roche and Shionogi under the terms of a 2016 agreement, gained approval in Japan in February, where it is marketed as Xofluza.
“The severity of the recent flu season underscores the need for new options beyond currently available treatments, and if approved, baloxavir marboxil would be the first flu medicine with a novel proposed mechanism of action in nearly 20 years,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “Baloxavir marboxil has been shown in clinical trials to decrease the duration of symptoms with one dose, and demonstrated a significant reduction in viral shedding in just one day.”
The FDA’s acceptance of Roche’s New Drug Application (NDA) is based on results from the phase III CAPSTONE-1 study, which demonstrated that baloxavir marboxil significantly reduced the time it took for patients’ influenza symptoms to alleviate.