Ionis partner GSK wins US approval for Hibsago to treat chronic hepatitis B
GSK•GSK received U.S. FDA approval for Hibsago, or bepirovirsen, with antiviral therapy for eligible adults with chronic hepatitis B. A six-month course improved functional cure outcomes versus placebo in Phase 3 results; Ionis is eligible for additional milestone payments and 10% to 12% tiered royalties on net sales.
1. FDA approval and use
GSK secured U.S. FDA approval for Hibsago, or bepirovirsen, with antiviral therapy for eligible adults with chronic hepatitis B. Use is limited to adults without cirrhosis whose infection is suppressed after at least six months of antiviral therapy. Boxed warnings cover liver flares and potentially life-threatening platelet reductions.
2. Trial results and agreement
Reported Phase 3 results showed that a six-month course improved functional cure outcomes versus placebo, allowing some patients to remain off treatment. GSK licensed bepirovirsen from Ionis Pharmaceuticals in 2019; the agreement provides additional milestone payments and tiered royalties of 10% to 12% on net sales.
