BioTuesdays

Eiger gets FDA breakthrough therapy designation for avexitide

Eiger BioPharmaceuticals’ (NASDAQ:EIGR) avexitide received FDA breakthrough therapy designation for the treatment of post-bariatric hypoglycemia (PBH).

PBH is characterized by dangerously low blood glucose levels following a meal in post-bariatric surgical patients. Avexitide is a glucagon-like peptide 1 antagonist that is designed to normalize insulin secretion and reduce hypoglycemia following a meal.

“Our avexitide PBH clinical program has dosed 54 patients across four Phase 2 studies, involving both inpatient and outpatient treatment, with promising results for patients suffering from post-bariatric hypoglycemia,” David Cory, Eiger’s president and CEO, said in a statement.

Avexitide has received FDA and EMA orphan drug designation for the treatment of hyperinsulinemic hypoglycemia and non-insulinoma pancreatogenous hypoglycemia syndrome (NIPHS), respectively, both of which include the PBH indication.

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