Eiger gets FDA breakthrough therapy designation for HDV drug candidate


Eiger BioPharmaceuticals’ (NASDAQ:EIGR) peginterferon lambda (lambda) received FDA breakthrough therapy designation for the treatment of hepatitis delta virus (HDV) infection.

HDV is the most severe form of human viral hepatitis and has no approved therapies.

Lambda is an interferon (IFN) that stimulates the immune system to protect against viral infection. The candidate targets a specific type of IFN receptor that is highly expressed on liver cells but has limited expression on hematopoietic and central nervous system cells.

“We look forward to continued collaboration with the FDA, now on four breakthrough therapy designation programs including both lonafarnib and lambda for HDV infection; lonafarnib for Hutchinson-Gilford Progeria Syndrome and Progeroid Laminopathies; and avexitide for post-bariatric hypoglycemia,” David Cory, Eiger’s president and CEO, said in a statement.

Lambda has previously been granted orphan drug and fast track designations by the FDA, and orphan drug designation by the EMA.