BioCentury
ARTICLE | Clinical News

Hepatitis D draft guidance outlines surrogate endpoints

November 1, 2019 10:07 PM UTC
Updated on Nov 2, 2019 at 12:22 AM UTC

Two companies have chronic hepatitis D virus therapies in Phase III trials with designs that could support accelerated approval, based on an FDA draft guidance released Friday.

There are no approved drugs for HDV, though pegylated IFNα -- approved for HBV, infection by which is required for HDV infection -- is the standard of care (SOC) in some parts of the world...