GSK to file for approval of twice-yearly hep B drug on positive Phase III data

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Source: Pharmaceutical Technology

Original: https://www.pharmaceutical-technology.com/news/gsk-to-file-for-approval-of-twice...

Published: Thu, 08 Jan 2026 11:03:19 +0000

GSK plans to submit an application for approval of bepirovirsen for the treatment of hepatitis B to the global regulatory body. The application is based on the positive results of the phase III clinical trial. The drug is intended for chronic hepatitis B. It should be administered twice a year, i.e. at six-month intervals. Bepirovirsen is developed by the pharmaceutical company GSK. The goal is to introduce a new treatment option for hepatitis B patients based on confirmed data from advanced phase clinical trials.