HDV inhibitor receives orphan drug designation by FDA, EMA
Lonafarnib has been granted orphan drug designation by the FDA and European Medicines Agency for the treatment of hepatitis delta virus infection, according to Eiger BioPharmaceuticals Inc., manufacturer of the drug.
With the status, Eiger will be able to market lonafarnib, an inhibitor of farnesyl transferase, exclusively and qualify for various development incentives, according to the release.
“We are committed to developing a therapy for the most insidious form of viral hepatitis, hepatitis delta, particularly as no FDA-approved therapies are currently available,” David Cory, president and CEO of Eiger BioPharmaceuticals, said in the release. “We are pleased that the FDA and EMA have granted orphan designation to lonafarnib as a first in class, potential new therapy for hepatitis delta virus (HDV), a disease with great unmet medical need.”
In a previous double blind, randomized phase 2a trial, a greater dose-dependent decrease in HDV RNA levels observed in patients with chronic HDV dosed with lonafarnib (0.7 log IU/mL decrease at 100 mg and 1.6 log IU/mL decrease at 200 mg) compared with patients who received placebo (0.08 log IU/mL decrease) after 28 days, according to the Eiger BioPharmaceuticals website.
The website further stated that lonafarnib was generally well tolerated in previous studies and is currently being investigated in further phase 2 trials.