Vir Biotechnology (VIR) late Monday said European regulators are expected to approve its product candidates to treat a relatively rare form of hepatitis and liver disease as an orphan drug.
A European Medicines Agency advisory panel recommended approving tobevibart and elebsiran as an orphan drug for the treatment of chronic hepatitis delta. The recommendation follows encouraging preliminary data from a phase 2 trial evaluating the efficacy of the drug combination in adults with hepatitis delta infections.
The US Food and Drug Administration in June issued a fast-track designation for the tobevibart and elebsirann, which will expedite the review process.
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