The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to avexitide (Eiger Biopharmaceuticals) for the treatment of post-bariatric hypoglycemia (PBH).

PBH is a potentially severe complication of bariatric surgery caused by excessive glucagon-like peptide-1 (GLP-1) secretion resulting in hyperinsulinemic hypoglycemia. Avexitide, a first in class, 31-amino acid GLP-1 antagonist, prevents postprandial hypoglycemia by reducing insulin secretion.

“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,” said David Cory, President and CEO of Eiger.

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Findings from the PREVENT study, which were presented at ENDO 2019, showed that treatment with avexitide resulted in a statistically significant reduction in hyperinsulinemic hypoglycemia in post-bariatric surgical patients who experienced PBH. The most common adverse reactions reported during the trial included injection site bruising, nausea, and headaches.

Avexitide was previously granted Orphan Drug designation by the FDA for the treatment of hyperinsulinemic hypoglycemia.

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