US FDA approves GSK's hepatitis B drug, offering patients chance to stop long-term treatment
GSK•The FDA approved GSK's Hibsago, the first approved antisense oligonucleotide for chronic hepatitis B. GSK expects peak annual sales of more than £2 billion for the drug.
1. FDA approval
The FDA approved GSK's Hibsago, chemically known as bepirovirsen, to help patients keep hepatitis B under control after stopping treatment. It is the first FDA-approved antisense oligonucleotide for chronic hepatitis B.
2. Sales and development
GSK expects peak annual sales of more than £2 billion ($2.68 billion) for Hibsago and says it is central to plans to reach more than £40 billion in annual revenue by 2031. The drug has also been approved in Japan and is under regulatory review in China and Europe.
3. Trial results and market
In clinical trials, nearly one in five patients achieved undetectable levels of the virus and stayed off antiviral treatment for at least six months. More than 250 million people globally live with chronic hepatitis B, and current standard-of-care treatments help 1% to 4% of patients clear the virus for a sustained period. Ionis Pharmaceuticals licensed the drug to GSK and is eligible for milestone payments; Aligos Therapeutics is developing a rival therapy.
