Lonafarnib NDA accepted for chronic hepatitis D
- Sponsor
- EIT Pharma
- Drug
- lonafarnib
- Indication
- chronic hepatitis D
FDA accepted EIT Pharma's NDA for lonafarnib, a first-in-class oral farnesyltransferase inhibitor, for the treatment of chronic hepatitis D. The application is supported by the Phase 3 D-LIVR trial and carries Breakthrough Therapy, Fast Track, and Orphan Drug designations.
What this means
Lonafarnib is an oral farnesyltransferase inhibitor being developed for chronic hepatitis D, a severe liver disease that only occurs in people already infected with hepatitis B. HDV depends on the host's farnesyltransferase enzyme to complete its lifecycle, and blocking that step prevents the virus from assembling infectious particles. EIT Pharma's NDA is supported by the Phase 3 D-LIVR trial and carries Breakthrough Therapy, Fast Track, and Orphan Drug designations. If approved, lonafarnib would be the first oral therapy for chronic hepatitis D in the U.S., where no oral treatments are currently approved.
Drug Watch — recent news on lonafarnib
- EIT Pharma secures USD 35m Series A to advance lonafarnib in hepatitis D - AllSci
- EIT Pharma - The Pharma Letter
- EIT Pharma raises $35 million as hepatitis D candidate sits with FDA - The Pharma Letter
- EIT Pharma Raises $35 Million Series A to Advance Lonafarnib - citybiz
- EIT Pharma Closes Oversubscribed $35 Million Series A Round, Led by Propel Bio Partners - Morningstar