Vir Biotechnology Secures EMA Orphan Drug Designation for Tobevibart and Elebsiran in Treating Chronic Hepatitis Delta

Vir Biotechnology, Inc. has announced a significant milestone in the fight against chronic hepatitis delta (CHD). 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 treating CHD. This decision is supported by promising preliminary data from the Phase 2 SOLSTICE trial.

Publish Date: 18-11-2024 Source: Vir Biotechnology, Inc.

Hepatitis delta, the most severe form of viral hepatitis in humans, is caused by infection with the hepatitis delta virus (HDV), which stands alone in the genus Deltaviridae. This unique virus relies on the presence of the hepatitis B virus (HBV) for replication, forming a symbiotic relationship. HDV infection produces two forms of an RNA-binding protein, known as the long and small delta antigens (Ag), with the host cell providing essential proteins for replication, notably RNA-directed RNA polymerase activity. Consequently, HDV can only cause disease in individuals who are already infected with HBV. Transmission of HDV primarily occurs through the parenteral route, typically via exposure to contaminated blood or blood products. The hepatitis delta virus expresses a single protein, the hepatitis delta antigen (HDAg), which forms a nucleocapsid-like structure with the viral genome. There are two forms of HDAg: small and large. These antigens and the single-stranded RNA genome are enveloped in a lipid membrane embedded with surface antigen proteins derived from HBV (HBsAg). HDV is distributed worldwide, with its prevalence locally dependent on the prevalence of HBV. It’s estimated that approximately 5% of individuals carrying HBsAg worldwide are co-infected with HDV.

The incidence of HDV-related disease tends to increase with age, peaking between 50 and 59 years, then declining slightly by age 70.

However, the current Hepatitis Delta Virus (HDV) Infection treatment market share, market uptake, and attribute analysis concerning the most potential emerging therapies (Myrcludex B, Bulevirtide, HH-003, etc..) has been provided under the market outlook section of the study covering 8 MM countries; The United States, EU5 (Germany, Spain, France, Italy, UK) Japan and China.

In terms of pharmacologic therapies, several pharmaceutical products are being approved and under different phases of development for the Hepatitis Delta Virus (HDV) Infection treatment. The key companies in the advanced development stage are Hepatera Ltd., Gilead Sciences, Huahui Health, etc..

Based on solid domain and business knowledge, Thelansis Knowledge Partners has published the market outlook forecast report on Hepatitis Delta Virus (HDV) Infection to provide a clear understanding of disease area background, epidemiology, current and future competitions, the country-specific standard of care, and the complete market forecast for 2023 to 2033.

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Thelansis specializes in pharmaceutical market outlook and market forecast reports. We published reports across the therapeutic area, including rare / ultra-rare and mainstream indications. Over the period, we have built a robust repository of 6,000+ Bio-pharma reports that cover Epidemiology studies and Market forecasting based on the KOL opinions.

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