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Vir Biotechnology Receives Positive Opinion on Orphan Drug Designation for Tobevibart and Elebsiran in Chronic Hepatitis Delta from European Medicines Agency
– Orphan designation in E.U. supports development of treatments for life-threatening or chronically debilitating conditions with significant unmet medical
About this update from Vir Biotechnology, Inc.
[{"type":"text","content":"\n– Orphan designation in E.U. supports development of treatments for life-threatening or chronically debilitating conditions with significant unmet medical need –\n\n\n– Phase 2 SOLSTICE 24-week primary endpoint data for tobevibart and elebsiran in chronic hepatitis delta to be presented today at AASLD The Liver Meeting –\n\n\n– Positive opinion on E.U. orphan drug designation follows U.S. FDA fast track designation, highlighting growing recognition of the potential of tobevibart and elebsiran in chronic hepatitis delta –\n\n\n SAN FRANCISCO--(BUSINESS WIRE)--\nVir Biotechnology, Inc. (Nasdaq: VIR) today announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP), has issued a positive opinion on the application for orphan drug designation of tobevibart and elebsiran for the treatment of chronic hepatitis delta (CHD). This opinion is based on encouraging preliminary data from the Phase 2 SOLSTICE trial. Vir Biotechnology will present 24-week data from the Phase 2 SOLSTICE trial at AASLD The Liver Meeting® in San Diego, CA, on November 18 at 6.15 p.m. PT. An investor conference call is scheduled for November 19, 2024, at 5.15 a.m. PT / 8.15 a.m. ET.\n\n\nCHD is a severe, progressive liver disease caused by the hepatitis delta virus (HDV)1. It is considered the most aggressive form of chronic viral hepatitis2, with patients often progressing to cirrhosis and liver failure within 5 years of infection3. Currently, there is no approved treatment in the United States, and treatment options are limited in the European Union and globally.\n\n\n“Chronic hepatitis delta dramatically raises the risk of severe liver disease, including cancer, and eventually death, so new therapeutic options are urgently needed,” said Mark Eisner, M.D., M.P.H., Executive Vice President and Chief Medical Officer, Vir Biotechnology. “The COMP’s positive opinion on tobevibart and elebsiran reflects the potential of this combination to address a critical gap in hepatitis delta care. Our clinical data to date has been encouraging, suggesting that this approach could meaningfully improve outcomes for patients living with this devastating disease.”\n\n\nThe European Commission will evaluate the COMP’s positive opinion and consider tobevibart and elebsiran for orphan drug designation. This designation is for medicines intended ...