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FDA reviewing new GSK treatment with priority status

Encouraging news in hepatitis B research!

GSK announced today (April 28, 2026) that the U.S. FDA is reviewing a new treatment, bepirovirsen, with priority status and Breakthrough Therapy Designation. In clinical trials, more patients reached a “functional cure” with bepirovirsen compared to current therapies. A decision by the FDA is expected by Oct. 26, 2026. While not yet approved, this step forward brings great hope for more effective treatment options in the near future. GSK has posted its news release here.

 

There is other news this week in related drug development.

Mirum Pharmaceuticals Announces Primary Endpoint Met in Phase 2b Portion of the AZURE-1 Study of Brelovitug in Chronic Hepatitis Delta Virus

Mirum Pharmaceuticals, Inc., a leading rare disease company, announced today (April 27, 2026) the primary endpoint was met in the Phase 2b portion of the AZURE-1 study evaluating brelovitug, an investigational monoclonal antibody designed to bind hepatitis B surface antigen (HBsAg), for the treatment of chronic hepatitis delta virus (HDV). Mirum has posted its news release here.