Gilead files first hepatitis delta therapy with FDA

Gilead Sciences has submitted its marketing application for bulevirtide, its antiviral therapy for rare hepatitis delta virus (HDV) infections, to the FDA.

If approved, bulevirtide will be the first drug to be approved in the US for HDV, a virus that exists only as a co-infection with hepatitis B virus (HBV). It occurs in around 5% of the estimated 257 million people around the world who are chronically infected with HBV – around 12 million people.