BioCentury
ARTICLE | Regulation

Leading in liver

How FDA is advancing surrogate endpoint understanding in liver disease

April 18, 2016 7:00 AM UTC

FDA is taking an active role in developing surrogate endpoints for liver diseases, and used an advisory panel meeting early this month to get advice on tackling some of the complexities involved. Companies working in primary biliary cholangitis may have to carefully define both patient populations and endpoints, because treatment effects and endpoint sensitivity may vary by stage of disease.

FDA's Gastrointestinal Drugs Advisory Committee met April 7 to discuss an application from Intercept Pharmaceuticals Inc. seeking accelerated approval of Ocaliva obeticholic acid to treat primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA), and as monotherapy for patients who cannot tolerate UDCA...