EMA Panel Backs Orphan Drug Status for Vir's Tobevibart in Hepatitis Delta

Key Insights

• The European Medicines Agency (EMA) panel supports orphan drug designation for Vir Biotechnology's tobevibart and elebsiran combination therapy.
• The designation targets the treatment of chronic hepatitis delta (CHD), a severe liver disease with limited treatment options.
• This decision is based on promising early data from the Phase 2 SOLSTICE trial, with detailed results to be presented at The Liver Meeting®.

Vir Biotechnology has received a positive opinion from the European Medicines Agency's (EMA) Committee for Orphan Medicinal Products regarding its application for orphan drug designation for tobevibart and elebsiran. This combination therapy is intended for the treatment of chronic hepatitis delta (CHD). The decision is based on encouraging preliminary data derived from the Phase 2 SOLSTICE trial.

The 24-week data from the Phase 2 SOLSTICE trial is scheduled to be presented at AASLD The Liver Meeting® in San Diego, CA, on November 18. An investor conference call to discuss the data is scheduled for November 19, 2024.

The Unmet Need in Hepatitis Delta

Chronic hepatitis delta is a severe and progressive liver disease caused by the hepatitis delta virus (HDV). 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.