BioSpace· Tristan Manalac·· 4 hours agoPickScore92
GSK, Ionis win FDA nod for hepatitis B functional cure that controls virus after treatment
In brief
The FDA has approved bepirovirsen, from GSK and Ionis Pharmaceuticals, under the brand name Hibsago, for use in combination with NRTIs to treat adults with chronic hepatitis B who have no liver fibrosis.
Why it matters
Phase 3 B-Well study provides placebo-controlled data overall and in the low baseline HBsAg subgroup, helping identify candidates for functional cure.
Source: BioSpace