FDA approves GSK drug Hibsago for chronic hepatitis B

The US Food and Drug Administration (FDA) has approved Hibsago, a new medication developed by GSK, for the treatment of chronic hepatitis B in adults. This marks the first approval of an antisense oligonucleotide for this infectious disease.

In clinical trials, patients received injections for up to 24 weeks alongside their existing antiviral medication. The treatment aims to allow selected patients to maintain long-term viral control even after discontinuing permanent antiviral therapies. Approximately one-quarter of study participants met the criteria to stop their previous medications, with 19 percent maintaining permanent viral control 24 weeks after all treatments ended.

The drug was granted breakthrough therapy status and received accelerated approval. It is intended for adult patients without liver cirrhosis who have been treated with nucleoside analogs for at least six months and demonstrate a low viral load.