GSK plc (GSK.L) Monday said its investigational drug in chronic hepatitis B bepirovirsen received Fast Track designation from the US Food and Drug Administration (FDA).
The designation was supported by data from the phase IIb trials B-Clear and B-Sure, which evaluated the efficacy, safety and durability of response of bepirovirsen in people with chronic hepatitis B.
A confirmatory Phase 3 study of bepirovirsen dubbed B-Well, is ongoing.
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