Kirkland, Washington, August,11, 2026
EIT Pharma, Inc. has announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for lonafarnib for the treatment of chronic hepatitis D (CHD). The regulatory milestone marks an important step toward potentially introducing an oral treatment option for one of the most serious forms of viral hepatitis. The NDA is supported by data from the Phase 3 D-LIVR study, described by the company as the largest clinical trial conducted to date in chronic hepatitis D, as well as earlier clinical, nonclinical and manufacturing data. Lonafarnib remains an investigational therapy and has not been approved by the FDA or any other regulatory authority for chronic hepatitis D.
FDA Accepts Lonafarnib New Drug Application
The FDA’s acceptance of the NDA means the agency will review EIT Pharma’s application for lonafarnib in chronic hepatitis D, a serious liver disease caused by hepatitis D virus (HDV) in people who already have hepatitis B virus (HBV) infection. According to EIT Pharma, CHD can progress to cirrhosis, liver failure, liver cancer and death, while treatment options remain limited in the United States. Lonafarnib is an investigational first-in-class oral therapy candidate designed to target a key step in the hepatitis D virus lifecycle. The candidate has previously received several FDA regulatory designations, including Breakthrough Therapy, Fast Track and Orphan Drug designations, reflecting the significant unmet medical need associated with chronic hepatitis D.
EIT Pharma acquired the late-stage lonafarnib program in 2024 and subsequently worked with regulatory, scientific and medical collaborators to complete the NDA submission. The company is now preparing for potential commercialization while continuing to work with the FDA throughout the review process. However, FDA acceptance of an NDA does not mean the medicine has been approved, and the agency’s review will determine whether lonafarnib can eventually be made available for CHD.
Phase 3 D-LIVR Study Supports NDA
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The NDA is supported by results from the global, randomized, placebo-controlled Phase 3 D-LIVR study, which enrolled more than 400 patients across 21 countries. Participants were evaluated over 48 weeks, providing late-stage clinical evidence for lonafarnib-based treatment regimens in people with chronic hepatitis D. EIT Pharma also included Phase 1/2 clinical data, nonclinical information and manufacturing data as part of the NDA package. The company said the D-LIVR program provides the clinical foundation for advancing lonafarnib into regulatory review and potentially toward commercialization.
The Phase 3 study represents an important milestone in the development of therapies for CHD because the disease remains associated with substantial long-term health risks. EIT Pharma said people living with chronic hepatitis D need therapies that can target distinct steps in the HDV lifecycle, supporting the company’s focus on developing an oral treatment approach for the disease.
Lonafarnib Targets Unmet Need in Hepatitis D
If approved, lonafarnib could potentially provide a new oral treatment option for people living with chronic hepatitis D. EIT Pharma highlighted several potential practical characteristics of the candidate, including oral administration and room-temperature storage, which may offer advantages related to treatment accessibility and management. The company also believes lonafarnib could potentially contribute to long-term clinical benefit, although such potential benefits remain subject to regulatory review and confirmation of safety and efficacy. Chronic hepatitis D occurs only in individuals who have hepatitis B infection and can result in severe and progressive liver disease.
Despite the serious burden associated with CHD, EIT Pharma notes that there are currently no FDA-approved oral therapies specifically for chronic hepatitis D in the United States. The FDA acceptance of the lonafarnib NDA therefore represents a significant regulatory milestone for EIT Pharma and the broader infectious disease pharmaceutical sector. The company will continue preparing for potential commercialization while collaborating with the FDA during the review. The outcome of the regulatory process will determine whether lonafarnib can become a new treatment option for patients with chronic hepatitis D.
Source: EIT Pharma press release
