Genentech, a subsidiary of Roche, announced that the U.S. Food and Drug Administration has accepted a New Drug Application (NDA) and granted priority review for baloxavir marboxil as a single-dose, oral treatment for acute, uncomplicated influenza in people 12 years and older. The FDA is expected to make a decision on approval by Dec. 24, 2018.
Baloxavir marboxil is a first-in-class, single-dose investigational oral medicine with a novel proposed mechanism of action designed to target the flu virus, including oseltamivir-resistant strains and avian strains (H7N9, H5N1). Unlike other currently available antiviral treatments, baloxavir marboxil is designed to inhibit the cap-dependent endonuclease protein within the flu virus, which is essential for viral replication.
The NDA is based on results from the Phase III CAPSTONE-1 study of a single dose of baloxavir marboxil compared with placebo or oseltamivir 75 mg, twice daily for five days, in otherwise healthy people with the flu. Additionally, results from a placebo-controlled Phase II study in otherwise healthy people with the flu are included as supporting data in the NDA.
Baloxavir marboxil is being studied in an ongoing Phase III development program including pediatric populations with influenza.
Baloxavir marboxil was discovered by Shionogi & Co. and is being developed globally by Roche and Shionogi & Co. Roche holds worldwide rights to baloxavir marboxil excluding Japan and Taiwan, which will be retained exclusively by Shionogi & Co.
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