Vir receives FDA, EMA designations for tobevibart and elebsiran

Vir Biotechnology (VIR) announced that tobevibart and elebsiran have received U.S. Food and Drug Administration Breakthrough Therapy designation and European Medicines Agency Priority Medicines designation for the treatment of chronic hepatitis delta. 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, U.S. Vir Biotechnology’s Phase 3 ECLIPSE registrational program evaluating tobevibart and elebsiran in CHD will commence in the first half of 2025. CHD is a chronic, progressive liver disease caused by the hepatitis delta virus and is the most severe form of chronic viral hepatitis. CHD increases the risk of liver cancer and accelerates progression to cirrhosis and liver failure, which often occurs within 5 years of infection3. There is no approved treatment in the U.S., and options are limited in the European Union and globally. “Chronic hepatitis delta has devastating effects on liver and overall health, yet people living with this condition are still waiting for highly effective therapeutic options,” said Mark Eisner, M.D., M.P.H., Executive Vice President and Chief Medical Officer, Vir Biotechnology. “The Phase 2 SOLSTICE trial data suggests that tobevibart and elebsiran can rapidly and deeply suppress the hepatitis delta virus, driving it to undetectable levels. Receiving FDA Breakthrough Therapy and European PRIME designations recognizes this combination’s potential to transform the lives of people living with CHD. We look forward to advancing the Phase 3 ECLIPSE program as quickly as possible.”