Vir Biotechnology gets positive opinion on orphan drug designation for Tobevibar

Vir Biotechnology (VIR) “announced that the European Medicines Agency Committee for Orphan Medicinal Products, has issued a positive opinion on the application for orphan drug designation of tobevibart and elebsiran for the treatment of chronic hepatitis delta. 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(R) 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. CHD is a severe, progressive liver disease caused by the hepatitis delta virus (HDV)1. It is considered the most aggressive form of chronic viral hepatitis, with patients often progressing to cirrhosis and liver failure within 5 years of infection. Currently, there is no approved treatment in the United States, and treatment options are limited in the European Union and globally.”