GSK Canada reported that Health Canada has accepted a new drug submission (NDS) for bepirovirsen, an investigational antisense oligonucleotide (ASO) for the treatment of adults with chronic hepatitis B (CHB) and will review it under the agency’s priority review policy. Bepirovirsen is being developed as a potential functional cure regimen for CHB, and the Canadian filing follows earlier regulatory submissions in Japan, China, the European Union, and the United States. In the U.S., bepirovirsen has received Breakthrough Therapy designation and previously Fast Track status from the Food and Drug Administration.
Chronic hepatitis B remains a public health concern in Canada, where an estimated 262,000 people are living with CHB. Current standard-of-care nucleos(t)ide analogue therapies typically require lifelong treatment, and functional cure rates are approximately 1%. A functional cure is defined as undetectable hepatitis B virus DNA and hepatitis B surface antigen (HBsAg) in the blood for at least 24 weeks after stopping all treatment, indicating that viral control is maintained by the immune system without ongoing medication. Globally, CHB is estimated to contribute to about 56% of liver cancer cases.
The Canadian NDS for bepirovirsen is supported by positive Phase III results from the B‑Well 1 and B‑Well 2 trials. In these studies, bepirovirsen added to standard of care achieved statistically significant and clinically meaningful functional cure rates compared with standard of care alone across all ranked endpoints, with an acceptable safety and tolerability profile consistent with prior studies. Detailed data from the B‑Well trials are planned for presentation at the European Association for the Study of the Liver (EASL) Congress and submission to a peer‑reviewed journal later in 2026.
GSK noted that the priority review designation in Canada recognizes both the unmet need in chronic hepatitis B and the potential of bepirovirsen to provide a new treatment approach. Bepirovirsen’s safety and effectiveness remain under investigation, and it has not yet received marketing authorization in Canada or any other country.
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