Eiger BioPharmaceuticals (EIGR) Announces FDA Breakthrough Therapy Designation for Avexitide for Treatment of Congenital Hyperinsulinism
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Eiger BioPharmaceuticals, Inc. (Nasdaq: EIGR), a commercial-stage biopharmaceutical company focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for avexitide for the treatment of congenital hyperinsulism (HI).
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 three completed Phase 2 studies in 39 neonates, children and adolescents with congenital hyperinsulinism. Avexitide is a targeted, first-in-class, GLP-1 antagonist in development for the treatment of metabolic disorders, including congential hyperinsulinism, an ultra-rare, life-threatening, pediatric disorder of persistent hypoglycemia that results in irreversible brain damage in up to 50% of children.
"Avexitide represents a promising, targeted approach for the treatment of congenital hyperinsulinism, an urgent, unmet medical need with no approved therapy," said Colleen Craig, MD, Vice President of Metabolic Diseases at Eiger. "We look forward to continued collaboration with the FDA."
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