GSK wins FDA approval for its hepatitis B drug
- STAT reports that GSK has won FDA approval for its hepatitis B drug.
- The drug extended functional cures to far more patients than previous methods, according to the report.
- Details beyond the headline were not available to us; the product is understood to be the antisense bepirovirsen.
💡 Points
A functional-cure label in hepatitis B is a landmark for the field, and GSK gets it with an antisense oligo, not a small molecule or antibody. The commercial question is uptake: finite treatment courses mean less recurring revenue per patient, but a large, long-diagnosed population. Watch Vir, Arbutus and the Chinese siRNA players, who now have a bar to clear.