What's Happening?
GSK is preparing to file for approval of its antisense-based drug, bepirovirsen, as a potential first-in-class treatment for chronic hepatitis B (CHB). The drug has shown promising results in two phase 3 trials, B-Well 1 and B-Well 2, which involved 1,800 patients across 29 countries. Bepirovirsen achieved a significantly higher functional cure rate compared to placebo, with more patients clearing the hepatitis B surface antigen (HBsAg) from their blood and maintaining undetectable levels for at least 24 weeks post-treatment. CHB is a significant global health issue, affecting over 250 million people and being the leading cause of liver cancer. The drug, administered as a weekly subcutaneous injection over six months, demonstrated an acceptable
safety and tolerability profile. GSK plans to file for global approval within the next three months, following its fast-track designation by the FDA in 2024.
Why It's Important?
The development of bepirovirsen represents a significant advancement in the treatment of chronic hepatitis B, a disease that leads to severe liver complications and high mortality rates. Achieving a functional cure could transform treatment goals, allowing the immune system to control the infection without ongoing medication. This could significantly reduce the risk of liver cancer and other long-term complications. The potential market for a hepatitis B functional cure is substantial, with analysts comparing it to the hepatitis C virus market, which peaked at around $10 billion annually. GSK's progress with bepirovirsen could lead to a major breakthrough in public health, offering hope to millions affected by CHB.
What's Next?
GSK is set to file for approval of bepirovirsen globally within the next three months. The company is also conducting a long-term extension study, B-Sure, to follow patients for approximately three years, with results expected in 2029. The success of bepirovirsen could pave the way for its use as a backbone in future sequential therapies. As GSK moves forward with regulatory filings, the pharmaceutical industry and healthcare providers will be closely monitoring the drug's approval process and market introduction.
