FDA approves novel flu drug Xofluza

Genentech announced late Wednesday that the US Food and Drug Administration has approved Xofluza(baloxavir marboxil) for the treatment of acute, uncomplicated influenza, or flu, in people 12 years of age and older who have had flu symptoms for no more than 48 hours.

This approval follows one of the deadliest flu seasons in four decades, with the US Centers for Disease Control and Prevention (CDC) estimating more than 900,000 hospitalizations and 80,000 deaths in the 2017-2018 flu season, comments Genentech, a wholly-owned US subsidiary of Swiss pharma giant Roche (ROG: SIX).

Xofluza is a first-in-class, single-dose oral medicine with a novel proposed mechanism of action that inhibits polymerase acidic endonuclease, an enzyme essential for viral replication.Xofluza has demonstrated efficacy against a wide range of influenza viruses, including oseltamivir-resistant strains and avian strains (H7N9, H5N1) in non-clinical studies.