AstraZeneca has said that the FDA has approved a new indication for its anti-ulcer drug Nexium in the treatment of Zollinger-Ellison Syndrome.
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Nexium, a proton pump inhibitor, is already is indicated for the treatment of gastroesophageal reflux disease and heartburn. Nexium is also is used to reduce the risk of gastric ulcers.
Zollinger-Ellison Syndrome is a rare but serious chronic condition characterized by the development of tumors that secrete excessive levels of gastrin, a hormone that stimulates acid production by the stomach.
“Patients with this condition require long-term antisecretory therapy to reduce their acid output to levels that are not injurious,” said David Metz, Professor of Medicine, Division of Gastroenterology, University of Pennsylvania. “Nexium provides early, effective, and sustained acid suppression to help in the management of this disease.”
The new indication for Nexium is based on clinical data that demonstrated Nexium effectively maintains basal acid output control in this patient population. Nexium was well tolerated throughout the trial.