Eiger BioPharmaceuticals, Inc. (Nasdaq: EIGR), a commercial-stage biopharmaceutical company focused on the development of innovative therapies to...
PALO ALTO, Calif., Feb. 23, 2021 /PRNewswire/ -- Eiger BioPharmaceuticals, Inc (Nasdaq: EIGR), a commercial-stage biopharmaceutical company focused on the development and commercialization of foundational therapies for Hepatitis Delta Virus (HDV) infection, today announced that positive results from the Phase 2 PREVENT study of Avexitide in patients with severe Post-Bariatric Hypoglycemia (PBH) were published in Journal of Clinical Endocrinology & Metabolism (Craig, C.M. et al, 2021).
Eiger BioPharmaceuticals, Inc. (Nasdaq: EIGR), focused on the development and commercialization of targeted therapies for rare and ultra-rare diseases, today announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for avexitide for the treatment of post-bariatric hypoglycemia (PBH). FDA Breakthrough Therapy Designation involves a fast track development and FDA review process with guidance designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases. PBH is a chronic condition occurring in post-bariatric surgical patients leading to dangerously low, postprandial blood glucose levels. Severe PBH episodes can result in altered mental status, loss of consciousness, seizures, and coma. Due to increasing morbid obesity, the number of bariatric surgeries are increasing, leading to an increased number of patients suffering from PBH. Avexitide is a targeted, first-in-class, GLP-1 antagonist in development for the treatment of PBH, a chronic, debilitating disorder for which there is no approved treatment.