Single-Dose Flu Drug Given Priority Review by FDA

Genentech’s baloxavir marboxil, an experimental, single-dose flu drug, has been given priority review by the U.S. Food and Drug Administration (FDA). Baloxavir marboxil is taken by mouth and behaves in a different way than other antivirals by targeting a protein that is critical for the replication of the influenza virus. It can also tackle various flu varieties such as H7N9 and H5N1. “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 Genentech chief medical officer Sandra Horning, MD.