Posted by Michael Wonder on 20 Aug 2019
Eiger announces FDA breakthrough therapy designation for peginterferon lambda for treatment of hepatitis delta virus infection
20 August 2019 - Fourth Eiger program granted breakthrough therapy designation.
Eiger BioPharmaceuticals today announced that the FDA 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 2 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.
