Priority Review for Genentech's flu therapy

Genentech Inc. said FDA accepted and granted Priority Review to its NDA for baloxavir marboxil 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...