Key facts: GSK plc Sponsored ADR FDA clears Hibsago; Jemperli Approved

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.

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.

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)