Kirkland’s EIT Pharma Announces Milestone for Drug Treating Chronic Hepatitis D
Kirkland-based EIT Pharma announced that the FDA has accepted its New Drug Application for Lonafarnib, an investigational oral treatment for chronic hepatitis D. The life-threatening liver disease affects people who already have hepatitis B and currently has no FDA-approved oral therapies in the United States.
The application is supported by the D-LIVR study, the largest clinical trial conducted to date in chronic hepatitis D, which enrolled more than 400 participants across 21 countries. “FDA acceptance of our NDA is an important milestone in our mission to bring a potential new oral treatment to people living with chronic hepatitis D,” said EIT Pharma CEO Leen Kawas.
EIT Pharma acquired the late-stage program in 2024 and will continue working with the FDA during its review while preparing for the potential commercialization of Lonafarnib. The company’s progress adds to the work of Washington-based biotechs developing new therapies for diseases with limited treatment options.