Eiger BioPharmaceuticals Gets Breakthrough Therapy Designation for Avexitide

By Chris Wack

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.

Eiger shares were up 9% to $8.24 in premarket trade.

Write to Chris Wack at [e-mail]

(END) Dow Jones Newswires

August 05, 2021 08:45 ET (12:45 GMT)

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