FDA grants fast track designation for HDV inhibitor

The FDA has granted Eiger BioPharmaceuticals fast track designation for lonafarnib in combination with Norvir for treatment of hepatitis delta virus infection, according to a press release.

Lonafarnib, an orally active agent that targets farnesyltransferase, inhibits the prenylation step of HDV replication inside liver cells and blocks the ability of the virus to multiply, according to the release. A phase 2 trial is currently underway to evaluate the drug when used in combination with Norvir (ritonavir, AbbVie).

“We are very pleased to receive fast track designation for lonafarnib to address a serious unmet medical need,” Joanne Quan, MD, chief medical officer at Eiger, said in the release. “It provides us with an outstanding opportunity to expeditiously develop lonafarnib for HDV infection. The granting of fast track status is an important achievement that can facilitate accelerated review of a [new drug application] submission based on the expected data from our development program with the goal of bringing the first approved treatment to HDV patients as quickly as possible.”

In a previous double blind, randomized phase 2a trial, a greater dose-dependent decrease in HDV RNA levels was 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.

Interim results of two clinical studies investigating the combination will be presented at the International Liver Congress this week in Vienna, Austria, according to the release.

Lonafarnib was granted orphan drug designation by the FDA and the European Medicines Agency in 2014.

Disclosure: Quan is an employee of Eiger BioPharmaceuticals, Inc.