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Xeris medicine for bariatric surgery complications gets orphan drug status in EU


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Xeris medicine for bariatric surgery complications gets orphan drug status in EU

Xeris Pharmaceuticals Inc. has been granted an orphan drug designation by the European Medicines Agency for its liquid glucagon therapy to treat a complication of gastric bypass surgery.

The ready-to-use liquid glucagon treats a spectrum of metabolic disorders called non-insulinoma pancreatogenous hypoglycemia syndrome that can occur after a patient receives gastric bypass surgery, including post-bariatric hypoglycemia, or PBH.

Chicago-based Xeris is evaluating the liquid glucagon in a phase 2 trial in patients with PBH, which is characterized by low blood sugars observed two to three hours after a meal. Initial results of the trial are due in the first half of 2019.

"PBH is a challenging complication of bariatric surgery with no reliable treatment today," Xeris Chairman and CEO Paul Edick said. "We are evaluating whether intermittent administration of our ready-to-use liquid glucagon may more rapidly and effectively address PBH, instead of relying upon dietary controls or medications that reduce glucose surges."

The EU's designation grants the company 10 years of market exclusivity for the product in this indication. Xeris was also granted a similar designation from the U.S. Food and Drug Administration in January.

Xeris is a specialty pharmaceutical company that develops ready-to-use injectable and infusible drug formulations.