USFDAApr 28, 2026, 07:31 AM
GSK Bepirovirsen gets US FDA Priority Review & Breakthrough Designation
AI Summary
GSK plc announced that the US FDA has accepted for priority review its New Drug Application for bepirovirsen, an investigational treatment for adults with chronic hepatitis B. The drug also received Breakthrough Therapy Designation, building on its prior Fast Track Designation, recognizing its potential for substantial improvement over existing therapies. The regulatory submission is supported by positive Phase III B-Well trials, and the FDA has set a PDUFA goal date of October 26, 2026.
Key Highlights
- US FDA accepted New Drug Application for bepirovirsen for priority review.
- Bepirovirsen granted Breakthrough Therapy Designation (BTD) by US FDA.
- BTD builds on Fast Track Designation received in February 2024.
- PDUFA goal date set by FDA for October 26, 2026.
- Regulatory submission supported by positive Phase III B-Well 1 and B-Well 2 trials.
- Chronic hepatitis B affects over 250 million people globally.
- Current standard of care functional cure rates are typically around 1%.