Vir Biotechnology receives FDA Breakthrough Therapy designation and EMA PRIME designation for tobevibart and elebsiran in chronic hepatitis delta
Vir Biotechnology, Inc. announced that tobevibart and elebsiran have received US Food and Drug Administration (FDA) Breakthrough Therapy designation and European Medicines Agency (EMA) Priority Medicines (PRIME) designation for the treatment of chronic hepatitis delta (CHD). The designations are supported by compelling positive safety and efficacy data from the Phase 2 SOLSTICE trial, from which the Company recently presented new data at AASLD The Liver Meeting® in San Diego, US. Vir Biotechnology’s Phase 3 ECLIPSE registrational program evaluating tobevibart and elebsiran in CHD will commence in the first half of 2025.
Read the full press release here.
Source : Vir Biotechnology, Inc.
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