- GSK has received Health Canada approval for Hibsago (bepirovirsen), the first and only finite therapy indicated to achieve functional cure of chronic hepatitis B (CHB) in eligible non-cirrhotic adults.
- The antisense oligonucleotide therapy is indicated for patients on nucleos(t)ide analogue treatment for at least six months, with HBV DNA below 90 IU/mL and HBsAg levels of 3,000 IU/mL or less.
- In the Phase III B-Well trials, functional cure rates reached 19% in patients with baseline HBsAg levels of 3,000 IU/mL or less and 26% in those at 1,000 IU/mL or less, versus 0% with placebo.
- Granted under Health Canada’s Priority Review policy, the approval offers a potential shift from lifelong disease management to finite treatment. Supply in Canada is expected in early 2027, with Japan and the US also having authorized the therapy.
Takeaways:
Health Canada’s approval positions GSK as a first mover in Canada’s chronic hepatitis B market with the first and only finite therapy indicated to achieve functional cure. The Phase III results could drive interest in antisense oligonucleotide-based treatments and shift the treatment landscape beyond lifelong viral suppression toward treatment-free disease control. The approval also creates a significant commercial opportunity for GSK in an underserved patient population, although market uptake will depend on pricing, reimbursement and the anticipated 2027 launch.
Source: CA Newswire
