MedPath

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

• 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®. • Chronic hepatitis delta is the most aggressive form of chronic viral hepatitis, often leading to cirrhosis and liver failure within five years.

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.
Subscribe Icon

Stay Updated with Our Daily Newsletter

Get the latest pharmaceutical insights, research highlights, and industry updates delivered to your inbox every day.

Related Topics

EMA Supports Orphan Drug Designation for Vir's HDV Therapy

The EMA has issued a positive opinion for orphan drug designation for tobevibart and elebsiran in treating chronic hepatitis delta (CHD).
The decision is supported by Phase 2 SOLSTICE trial data, presented at AASLD, showing encouraging preliminary results for the drug combination.

Vir Biotechnology's Hepatitis Delta Treatments Receive Orphan Drug Status from EMA

Vir Biotechnology's tobevibart and elebsiran receive positive opinion for orphan drug designation from the EMA for chronic hepatitis delta.
The orphan drug status offers incentives like scientific advice, fee reductions, and potential market exclusivity for ten years upon approval.

EMA Grants Orphan Drug Status to Vir Biotechnology's Tobevibart and Elebsiran for Chronic Hepatitis Delta

The European Medicines Agency (EMA) has granted orphan drug designation to tobevibart and elebsiran for treating chronic hepatitis delta (CHD).
This decision was influenced by encouraging preliminary data from Vir Biotechnology's Phase 2 SOLSTICE trial.

Vir Biotechnology Receives Positive EU Opinion for Orphan Drug Designation of Tobevibart and Elebsiran in Chronic Hepatitis Delta

The EMA's COMP issued a positive opinion for orphan drug designation of tobevibart and elebsiran for chronic hepatitis delta (CHD).
The decision was based on encouraging preliminary data from the Phase 2 SOLSTICE trial, with 24-week data presented at The Liver Meeting.

Vir Biotechnology Receives Positive EU Opinion for Hepatitis Delta Therapy

Vir Biotechnology's tobevibart and elebsiran receive positive opinion for orphan drug designation from the EMA for chronic hepatitis delta (CHD).
The decision follows encouraging preliminary data from the Phase 2 SOLSTICE trial, with full data to be presented at AASLD The Liver Meeting.

Vir Biotechnology Receives Positive EU Opinion for Orphan Drug Designation of Tobevibart and Elebsiran in Chronic Hepatitis Delta

The EMA's COMP issued a positive opinion for orphan drug designation of tobevibart and elebsiran for chronic hepatitis delta (CHD).
The decision was based on Phase 2 SOLSTICE trial data, which will be presented at AASLD The Liver Meeting.

Vir Biotechnology's Tobevibart and Elebsiran Show Promise in Chronic Hepatitis B Treatment

Vir Biotechnology announced positive end-of-treatment data from its Phase 2 MARCH trial, evaluating tobevibart and elebsiran combinations for chronic hepatitis B.
In participants with low baseline HBsAg, 39% achieved HBsAg loss with tobevibart + elebsiran, and 46% with the triplet regimen including pegylated interferon alfa.

Vir Biotechnology Advances Hepatitis Delta and B Programs with New Clinical Data

Vir Biotechnology is set to present Phase 2 SOLSTICE trial data of tobevibart and elebsiran for chronic hepatitis delta at AASLD.
The SOLSTICE trial's week 24 primary endpoint analysis will be shared, along with insights into hepatitis delta's economic impact.

Vir Biotechnology to Present Latest Hepatitis Delta and B Data at EASL Congress 2024

Vir Biotechnology, Inc. announced that three abstracts featuring new data from its chronic hepatitis delta and chronic hepatitis B programs will be presented at the EASL Congress 2024. The presentations will include findings from the Phase 2 SOLSTICE trial, focusing on the efficacy and safety of tobevibart and elebsiran.

Vir Biotechnology's Tobevibart and Elebsiran Receive FDA and EMA Designations for Chronic Hepatitis Delta Treatment

Vir Biotechnology has announced that its drugs, tobevibart and elebsiran, have been granted Breakthrough Therapy designation by the FDA and Priority Medicines designation by the EMA for treating chronic hepatitis delta (CHD). This decision is backed by positive safety and efficacy data from the Phase 2 SOLSTICE trial. The Phase 3 ECLIPSE registrational program is set to begin in the first half of 2025, aiming to provide a much-needed treatment option for CHD, a severe form of chronic viral hepatitis with no approved treatment in the U.S. and limited options globally.

Reference News

[1]
Vir Biotechnology gets positive opinion on orphan drug designation for Tobevibar
markets.businessinsider.com · Nov 19, 2024

Vir Biotechnology announced a positive opinion from the European Medicines Agency for orphan drug designation of tobevib...

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy