FDA approves Hibsago for chronic hepatitis B treatment

The U.S. Food and Drug Administration (FDA) has approved Hibsago (bepirovirsen), an injection developed by GSK, for the treatment of chronic hepatitis B virus (HBV) infection in certain adults without cirrhosis.

Hibsago is the first antisense oligonucleotide approved by the FDA for this purpose. It is intended for use in combination with existing antiviral therapies for patients who have been on antiviral treatment for at least six months and exhibit suppressed HBV levels in the blood alongside hepatitis B surface antigen (HBsAg) levels of 3,000 IU/mL or less.

The medication works by targeting the genetic instructions the virus uses to replicate itself and produce viral proteins, helping to reduce the amount of virus and HBsAg in the body. According to the FDA, this new approach may allow some patients to maintain viral control even after discontinuing all hepatitis B medications, a possibility not currently available with standard treatments.

Additionally, the FDA authorized the Roche Elecsys HBsAg II quant II RxDx test as a complementary diagnostic device to assist in patient selection and treatment monitoring.