Biotechnology company EIT Pharma Inc announced on Tuesday that the US Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for lonafarnib for the treatment of chronic hepatitis D.

Lonafarnib is an investigational first-in-class oral chronic hepatitis D therapy candidate that has previously received FDA Breakthrough Therapy designation, Fast Track designation, and Orphan Drug designation. Following its acquisition of the late-stage programme in 2024, EIT Pharma worked closely with regulators and scientific and medical collaborators to complete the NDA submission and is now working on preparations for commercialisation.

The NDA is supported by data from the Phase 3 D-LIVR study, the largest clinical trial conducted to date in chronic hepatitis D, and Phase 1/2 clinical data, nonclinical data, and manufacturing information. The global, randomised, placebo-controlled Phase 3 D-LIVR study enrolled over 400 patients across 21 countries and evaluated lonafarnib-based regimens over 48 weeks.