FDA approves Hibsago for some adults with hepatitis B

The U.S. Food and Drug Administration approved Hibsago, a new treatment for certain adults with chronic hepatitis B, on October 20, offering some patients a chance to stop taking their existing antiviral medicine while keeping the infection under control. Known generically as bepirovirsen, Hibsago is the first antisense oligonucleotide approved by the FDA for chronic hepatitis B. It is given by injection alongside existing antiviral treatment and works by targeting the virus’s genetic instructions, reducing viral material and hepatitis B surface antigen, a marker of infection. The treatment is not described as eliminating the virus from the body. The approval covers adults without cirrhosis who have taken antiviral medicine for at least six months and already have suppressed levels of the virus. They must also meet specified hepatitis B surface antigen criteria, including a level of 3,000 IU/mL or less confirmed through an authorized test. The FDA authorized a diagnostic test to help select and monitor patients. In two clinical trials, 24% of people who received Hibsago met criteria to stop their existing antiviral medicine, compared with none in the placebo groups. At 24...