FDA approves Hibsago for treatment of chronic hepatitis B

The US Food and Drug Administration (FDA) has granted approval for Hibsago (bepirovirsen), a new treatment for adults with chronic hepatitis B. Developed by GSK plc, Hibsago is the first antisense oligonucleotide therapy approved for this condition, specifically targeting patients without cirrhosis who have already undergone at least six months of antiviral therapy. This approval marks a significant shift in managing a disease that affects more than 250 million people worldwide.

The treatment works by targeting the genetic material of the hepatitis B virus to reduce viral levels. Clinical trial data revealed that 24% of participants were able to maintain viral control and discontinue their existing lifelong medications after using the new therapy. Dr. Wendy Carter of the FDA described the drug as an innovative approach that provides new hope for patients who previously faced indefinite daily treatment regimens to suppress the virus.

While the approval is a major milestone, the FDA included significant warnings regarding potential liver reactions and other serious side effects. Hibsago, which was licensed from Ionis Pharmaceuticals, is already approved in Japan and is currently under regulatory review in Europe and China. GSK expects the drug to be a major driver of revenue growth as it enters a market where several other biotech firms are also racing to develop rival therapies for chronic hepatitis B.