FDA & Regulation, Drugs & Devices Vital Biomedical News Staff FDA & Regulation, Drugs & Devices Vital Biomedical News Staff

FDA Approves Hibsago, a First-of-Its-Kind Hepatitis B Drug That Lets Some Patients Stop Treatment

The FDA has approved Hibsago (bepirovirsen), GSK's injectable antisense drug for chronic hepatitis B. In two phase 3 trials, about 19% of patients achieved a functional cure and could stop all treatment. The drug carries a boxed warning for liver reactions and low platelets.

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