GSK snags Japanese approval for first hepatitis B functional cure, Hibsago - Pharmaceutical Technology

The FDA accepted GSK's sBLA for dostarlimab (Jemperli) in locally advanced rectal cancer, setting a PDUFA date for February 2027. The application is based on AZUR-1 trial data showing a clinically meaningful response rate, according to GSK. If approved, dostarlimab would be the first immunotherapy for this indication, potentially avoiding conventional treatments.

Japan approved GSK's Hibsago (bepirovirsen) for chronic hepatitis B, the first functional cure for the disease. The approval is based on Phase III trial data showing a 19% functional cure rate. GSK licensed the drug from Ionis Pharmaceuticals and plans to seek approvals in other markets, including the US and China.

GSK received its first global approval for chronic hepatitis B drug bepirovirsen from Japanese regulators. Branded as Hibsago, it is the first functional cure treatment for CHB approved in Japan. The drug showed a 19% functional cure rate in Phase III trials, compared to 1% with current treatments. GSK licensed the drug from Ionis Pharmaceuticals.

GSK (LON:GSK) received Japan's first approval for its hepatitis B drug, Hibsago, and a U.S. FDA priority review for its cancer therapy, Jemperli. The company expects Hibsago to generate over £2 billion in peak annual sales, aiding its £40 billion revenue target by 2031. Jemperli's review for rectal cancer is set for February 2027, with potential for an earlier decision.

GSK announced the FDA accepted its application for priority review of Jemperli (dostarlimab) to treat certain rectal cancer patients. The PDUFA action date is February 2027, with potential for earlier review. The application is based on the AZUR-1 trial, which met its primary objective. Jemperli is not yet approved for this indication. GSK acquired the drug through its purchase of TESARO, which licensed it from AnaptysBio.

GSK announced the FDA accepted a priority review for Jemperli (dostarlimab) to treat certain rectal cancer patients. The application is based on positive trial data showing sustained clinical responses. The FDA set a PDUFA action date for February 2027, with potential for earlier review. Jemperli, if approved, could be the first immunotherapy to potentially eliminate or delay standard treatments for some patients.