Fourth Eiger BioPharma program granted Breakthrough Therapy status

California, USA-based rare diseases specialist Eiger BioPharmaceuticals (Nasdaq: EIGR) says that the US Food and Drug Administration has granted Breakthrough Therapy designation for peginterferon lambda (Lambda) for the treatment of hepatitis delta virus (HDV) infection.

Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).

Eiger’s application was supported by data from the Phase II LIMT Lambda monotherapy study in 33 HDV-infected patients. Lambda is a first-in-class type III interferon for the treatment of HDV, the most severe form of human viral hepatitis for which there is no approved therapy.