After Japan: US Authorizes Treatment for Chronic Hepatitis "B"

The US Food and Drug Administration approved a new drug for chronic hepatitis B, marketed as "Hepbago" and scientifically known as "Bepirovirsen," developed by the British company GSK. The drug targets the virus's genetic instructions and is intended for adults without liver cirrhosis. The approval followed regulatory clearance in Japan.

The US Food and Drug Administration (FDA) approved a new drug for the treatment of chronic hepatitis B, marketed as "Hepbago" and scientifically known as "Bepirovirsen," developed by the British company GSK. The drug relies on a technology that targets the virus's genetic instructions to reduce its activity, making it the first treatment in the class of anti-gene expression drugs approved by the US agency for this disease. The approval came after the drug received regulatory clearance in Japan, while authorities in China and Europe are still reviewing its approval applications. The approval is limited to adults who do not have liver cirrhosis and have received antiviral treatment for at least six months, with virus levels in the blood reduced to required limits. It also requires that the virus's surface antigen level not exceed three thousand international units per milliliter. The drug is used alongside the antiviral treatments patients already receive and is not an immediate replacement for them. The approval decision was based on results from two phase three clinical trials named "B-Well." The company has not disclosed the expected price of the treatment in the US or its commercial launch date.