Eiger BioPharmaceuticals Inc. said the U.S. Food and Drug Administration granted breakthrough therapy designation for avexitide for the treatment of congenital hyperinsulism.
The designation is a process designed to speed up 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.
Eiger said its application was supported by data from three completed Phase 2 studies in 39 neonates, children and adolescents with congenital hyperinsulinism. Avexitide is a targeted 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.
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