Posted by Michael Wonder on 17 Dec 2018
Eiger announces breakthrough therapy designation granted by FDA for lonafarnib for treatment of hepatitis delta virus infection
17 December 2018 - Phase 3 HDV “D-LIVR” international study initiating.
Eiger BioPharmaceuticals today announced that the FDA has granted breakthrough therapy designation for lonafarnib for the treatment of hepatitis delta virus (HDV) infection.
Lonafarnib is a first-in-class prenylation inhibitor for the treatment of HDV infection.
This breakthrough therapy designation is supported by data from Phase 2 clinical studies of lonafarnib-based treatment regimens in HDV-infected patients, achieving combined primary endpoints of ≥ 2 log10 decline in HDV RNA and normalisation of alanine aminotransferase which reflect an improvement in liver condition and virologic response rarely observed in untreated HDV patients.
