The US Food and Drug Administration (FDA) has approved an injectable drug from pharmaceutical company GSK for the treatment of adults with chronic hepatitis B who show no signs of liver cirrhosis. It is the world's first antisense oligonucleotide-based medicine capable of delivering a so-called functional cure for the disease, the website infohub.kz reports.
According to ScienceAlert, the therapy enables some patients to achieve long-term immune control of the virus and to stop taking standard antiviral pills for life.
The drug works by binding directly to the virus's genetic material in liver cells. This halts replication of the pathogen, lowers the concentration of viral proteins and helps restore the body's own immune response.
The regulator's decision is based on the results of two large clinical trials, B-Well 1 and B-Well 2, involving 1,838 patients in 29 countries. Participants received weekly subcutaneous injections of the drug for 24 weeks in combination with standard treatment, after which they stopped therapy.
About 19% of patients reached the primary endpoint of a functional cure: the hepatitis B surface antigen (HBsAg) and viral DNA were undetectable in their blood for more than six months after the course ended. Among patients with low baseline antigen levels, efficacy reached 28%, and 91% of those who responded to the therapy maintained remission for 96 weeks.
In August 2026, the drug received its first approval in Japan.