Eiger BioPharmaceuticals has announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for peginterferon lambda (Lambda) for the treatment of hepatitis delta virus (HDV) infection.
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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.
"We look forward to continued collaboration with the FDA, now on four Breakthrough Therapy Designation programs including both Lonafarnib and Lambda for hepatitis delta virus (HDV) infection, Lonafarnib for Hutchinson-Gilford Progeria Syndrome (Progeria) and Progeroid Laminopathies, and Avexitide for post-bariatric hypoglycemia (PBH)," said David Cory, President and CEO of Eiger.