Clinical Trials Arena on MSN
GSK to file for approval of twice-yearly hep B drug on positive Phase III data
GSK will be filing for approval of bepirovirsen in hepatitis B to global regulatory authorities based on the Phase III data.
GSK’s potential “functional cure” for hepatitis B drug has proven its worth in a pair of hotly anticipated phase 3 studies, setting up the pharma for a push to the FDA.
Topline data were announced from two phase 3 studies evaluating bepirovirsen for the treatment of chronic hepatitis B.
Hepatitis B is a viral infection that impacts the liver. To test for hepatitis B, a doctor can perform a blood test that detects hepatitis B surface antigens. A positive result indicates a hepatitis B ...
GSK will use promising results from two studies of its experimental chronic hepatitis B therapy to support planned regulatory ...
Zacks Investment Research on MSN
GSK's chronic hepatitis B drug meets goals in two late-stage studies
GSK plc GSK announced positive results from two phase III studies, B-Well 1 and B-Well 2, which evaluated its investigational ...
Though specific data for bepirovirsen remain under wraps, GSK plans to file for approval in the first quarter of 2026.
The hepatitis B surface antibody test (HBsAb) detects antibodies in the blood to determine if someone is immune to the hepatitis B virus (HBV). A negative or nonreactive result means the individual is ...
Background Hepatitis B virus (HBV) is a common cause of viral hepatitis with significant health complications including cirrhosis and hepatocellular carcinoma. Assays for hepatitis B surface antigen ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback