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2023-05-08| Trials & Approvals

Gilead’s HDV Drug Headed Towards European Approval Even With FDA Rejection

by Reed Slater
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Three years after gaining conditional approval from the European Commission to treat hepatitis delta virus (HDV), Gilead’s Hepcludex (bulevirtide) is on track for full approval with a positive opinion from the Committee for Medicinal Products for Human Use (CHMP). The news comes while Gilead is still working to remedy issues with the FDA, which led to a complete response letter (CLR) and is preventing approval in the U.S.

Related Article: The FDA Expands Use for Gilead Science’s HBV Treatment

Hepcludex’s Value in Europe

HDV is a severe form of viral hepatitis, affecting about 5% of people living with hepatitis B. Between the U.S. and Europe, about 230,000 people live with the disease, which can result in liver diseases like liver fibrosis and cirrhosis. Mortality rates are as high as 50% within five years of cirrhotic patients. 

The drug initially gained conditional approval in Europe in 2020 while it was under MYR Pharmaceuticals’ ownership. Gilead took over Hepcludex in 2021 after acquiring MYR for up to €1.45 billion in aggregate cash consideration.

Three years later, Gilead is still hard at work getting Hepcludex traditional approval in Europe. With some positive results from the Phase 3 MYR301 48-week study, Hepcludex could have some momentum going in its favor in Europe. 

In the most recent development, CHMP has adopted a positive opinion of Hepcludex to treat adults with chronic HDV and compensated liver disease. The committee based the recommendation for full marketing authorization on results from the MYR301 study. 

Frank Duff. M.D., Senior Vice President, Virology Therapeutic Area Head at Gilead, said, “The MYR301 Week 48 data supporting this recommendation for full approval demonstrates that with longer treatment with bulevirtide, higher response rates are achieved, meaning this rare, life-threatening disease can be better managed…This marks a significant step forward as it offers real hope to people living with HDV, who have previously faced an uncertain future.”

Less Certainty in the U.S.

In October last year, the FDA issued Gilead with a CLR for Hepcludex’s Biologics License Application (BLA), preventing the drug from gaining American approval and entering a lucrative market. 

Fortunately, the CLR did not indicate any safety or efficacy issues associated with Hepcludex and focused on concerns surrounding potential manufacturing and delivery problems. In its most recent press release, Gilead noted that it “remains in active discussions” with the regulatory agency to remedy the manufacturing and delivery issues with Hepcludex, paving the way for FDA approval. 

Even without a certain future in the U.S., Gilead can hold its head high with the most recent marketing authorization recommendation from CHMP. The recommendation lays a stronger foundation for Hepcludex’s traditional approval in Europe. 

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