Hibsago Hepatitis B Shot Kept Virus Controlled in Nearly 1 in 5 Off Treatment but Carries Boxed Warning

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.

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.

Ionis Pharmaceuticals' partner GSK received FDA approval for HIBSAGO (bepirovirsen), showing a 19% functional cure rate in Phase 3 trials for chronic hepatitis B. The approval was granted under priority review and Breakthrough Therapy Designation. Ionis is eligible for milestones and royalties. The label includes safety warnings.

GSK's new drug, Hibsago, received FDA approval for treating chronic hepatitis B, potentially offering a functional cure after a six-month treatment. Clinical trials showed 19% of patients achieved sustained viral control. The drug is expected to generate significant sales, with analysts projecting a growing market. GSK licensed the drug from Ionis Pharmaceuticals, which may receive up to $510 million in milestone payments.

The FDA approved GSK's Hibsago (bepirovirsen), a new injectable treatment for chronic hepatitis B in adults without cirrhosis. Clinical trials showed 24% of patients could discontinue antiviral therapy, with 19% maintaining viral control 24 weeks post-treatment. The drug carries significant safety risks, including liver reactions and bleeding. GSK received Fast Track and Breakthrough Therapy designations. (Source: IANS)