United States Greenlights Hibsago: A Breakthrough Hepatitis B Treatment Offering Hope Beyond Antivirals

The FDA approved dolutegravir, an HIV treatment, for newborns based on an international study. The study, involving UC San Diego and Boston Medical Center, found a safe dosing regimen for infants. The approval expands treatment options for HIV-infected newborns, according to the researchers.

GSK and Ionis' Hibsago (bepirovirsen) received FDA approval for chronic hepatitis B, offering a functional cure. Analysts at H.C. Wainwright see this as a significant milestone, opening the market for competitors like Gilead, Arrowhead, and Aligos. The drug is approved for a specific patient population, leaving opportunities for other therapies. Several companies will present data at the AASLD meeting in November.

H.C. Wainwright maintained a $100 price target for Ionis Pharmaceuticals (IONS) after GSK's Hibsago received FDA approval, which will generate royalties for Ionis. The stock is near its 52-week low, down 44% year-to-date. Analysts estimate Japan alone could generate $21M-$26M in annual royalties at peak. Other analysts have also recently upgraded or maintained positive ratings on IONS.

The FDA approved GSK's Hibsago (bepirovirsen) for chronic hepatitis B, the first antisense oligonucleotide for this use. It's for adults without cirrhosis who meet specific criteria. In trials, 19% of patients controlled the virus 24 weeks post-treatment. The drug carries a boxed warning for serious liver reactions and low platelet counts, requiring regular monitoring. Pricing and coverage details are not yet available.

Novartis's pelacarsen, co-developed with Ionis Pharmaceuticals, failed to reduce cardiovascular events despite lowering Lp(a) levels in a Phase 3 trial. The results challenge the Lp(a) targeting thesis and may impact other programs like olpasiran and lepodisiran. Analysts had forecasted $6B in peak annual U.S. sales for pelacarsen.

GSK's Hibsago received FDA approval for chronic hepatitis B in adults. Phase III trial showed 19% functional cure rate. Jemperli approved for rectal cancer. GSK plc Sponsored ADR (GSK) benefits from these regulatory wins.