Priority Review for Genentech's flu therapy

Genentech Inc. said FDA accepted and granted Priority Review to its NDA for baloxavir marboxil (RG6152, S-033188) to treat acute uncomplicated influenza in patients ages 12 and older. Its PDUFA date is Dec. 24.

The Roche (SIX:ROG; OTCQX:RHHBY) unit said the single-dose oral antiviral would be the first therapy with a new mechanism of action approved to treat influenza in nearly two decades. Baloxavir marboxil, a cap-dependent endonuclease inhibitor, is designed to target influenza A and B viruses, including those resistant to Roche's Tamiflu oseltamivir and avian strains such as H7N9 and H5N1...