FDA Approves GSK's Hibsago Injection for Chronic Hepatitis B, Bo

GSK plc (GSK) received FDA approval for Hibsago (bepirovirsen) to treat certain adult chronic hepatitis B patients. The drug is approved for use with NrtI therapy in patients without cirrhosis and with HBsAg ≤3000 IU/mL, following at least 6 months of NrtI treatment and suppressed HBV DNA. This marks GSK's second country approval for the drug, following Japan.

GSK's drug Hibsago (bepirovirsen) received approval for chronic hepatitis B treatment, showing 19% of trial participants had no detectable virus 24 weeks post-treatment. The six-month course offers potential functional cure and self-administration options. GSK licensed the drug from Ionis, with regulatory decisions pending in other regions.

GSK PLC announced FDA approval of Hibsago (generic name bepirovirsen) for chronic hepatitis B treatment. The drug, a first-in-class antisense oligonucleotide, showed 19% functional cure rates in trials. GSK shares closed up 0.7% at 1,868.50 pence in London. The approval was granted under priority review and breakthrough therapy designation, according to the company.

GSK's drug Hibsago (bepirovirsen) received FDA approval for treating chronic hepatitis B (CHB). The treatment, in combination with standard therapy, showed a 19% functional cure rate in phase III trials, significantly higher than the current standard of care. GSK licensed the drug from Ionis Pharmaceuticals and plans to advance regulatory submissions globally. CHB affects 1.7 million people in the US.

GSK's bepirovirsen (Hibsago) received FDA approval for chronic hepatitis B. Approval followed two trials showing 24% of patients stopped existing medication and 19% controlled HBV post-treatment. Roche's HBsAg II quant II RxDx was approved as a companion diagnostic. The treatment is for adults without cirrhosis, with specific HBV criteria, and carries a boxed warning for liver reactions and low platelet counts.

The US FDA has approved GSK's new hepatitis B drug, which may allow patients to stop long-term treatment. GSK's stock is up 0.73% today and 5.51% year-to-date. The approval could expand GSK's market share in hepatitis treatments.