Vir Biotech receives FDA Fast Track designation for hepatitis delta combination therapy.
Vir Biotechnology receives FDA clearance for IND application and Fast Track designation for tobevibart and elebsiran combo to treat hepatitis delta. The combination therapy, in Vir's Phase 2 SOLSTICE trial, demonstrates high virologic response, durability, and ALT normalization. FDA Fast Track aims to expedite development and review of drugs for serious conditions with unmet medical needs.
June 26, 2024
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