Gilead Receives FDA CRL for Bulevirtide

The FDA sent a Complete Response Letter (CRL) to Gilead yesterday regarding the company’s bulevirtide. In the letter, the federal agency said it had concerns about the manufacture and delivery of the therapy.

“While we are disappointed with this outcome, we remain confident in the benefits bulevirtide could potentially bring to people living with HDV in the U.S. Today’s news does not change the safety and efficacy profile observed in clinical trials to date,” Gilead Chief Medical Officer Merdad Parsey, MD, PhD, said in a statement. “We look 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.”

Bulevirtide was granted Breakthrough Therapy and Orphan Drug designations by the FDA. The therapy is not FDA approved in the US and is conditionally authorized in the European Economic Area and the United Kingdom.

Chronic HDV infection is the most severe form of viral hepatitis, with a poor prognosis and high rates of mortality. There is a significant unmet need for HDV treatment options in the United States.

Just a few weeks ago, Contagion reported on a study published in The Lancet Infectious Diseases, showed bulevirtide in combination with tenofovir disoproxil fumarate (TDF) had positive results for treating patients with coinfection of hepatitis B virus and hepatitis D virus in a recent phase 2 trial.