The US Food and Drug Administration (FDA) has declined to approve bulevirtide, Gilead Sciences' drug for the treatment of hepatitis delta virus (HDV) infection and compensated liver disease.
In a complete response letter, the FDA voiced concerns over the production and delivery of bulevirtide, an investigational, first-in-class HDV entry-inhibitor that received conditional approved in Europe in 2020.
The FDA did not request new studies to evaluate the safety and efficacy of bulevirtide.
"While we are disappointed with this outcome, we remain confident in the benefits bulevirtide could potentially bring to people living with HDV in the US," Merdad Parsey, MD, PhD, chief medical officer, Gilead Sciences, wrote in a news release.
Parsey said the FDA action "does not change the safety and efficacy profile observed in clinical trials to date."
As reported previously by Medscape Medical News, data from an ongoing phase 3 trial showed that after 48 weeks of treatment, almost half of those treated with bulevirtide achieved the combined primary endpoint of reduced or undetectable HDV RNA levels and normalized alanine aminotransferase levels.
Chronic HDV infection is the most severe form of viral hepatitis. It is associated with a poor prognosis and high mortality rates.
There are currently no approved treatments for HDV in the United States. Bulevirtide was granted breakthrough therapy and orphan drug designations by the FDA.
Parsey said the company looks forward to "continuing our active discussions with FDA so that we may bring bulevirtide to people living with HDV in the US as soon as possible."
This is the second manufacturing-related complete response letter Gilead has received in the past 8 months. In March, the FDA rejected the long-acting HIV drug lenacapavir. The drug was sanctioned in Europe and the United Kingdom in September.
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Cite this: FDA Rejects Bulevirtide for Hepatitis D - Medscape - Oct 31, 2022.