AstraZeneca receives FDA approval for NEXIUM I.V. to treat GERD with erosive esophagitis

AstraZeneca (NYSE: AZN) announced today that the U.S. Food and Drug Administration (FDA) has approved the use of NEXIUM® I.V. (esomeprazole sodium) for Injection for children ages greater than 1 month old for the short-term treatment of gastroesophageal reflux disease (GERD) with erosive esophagitis when oral therapy is not possible or appropriate. NEXIUM I.V. is the first proton pump inhibitor approved for children under one year old.

GERD is a condition in which the contents of the stomach back up into the esophagus. Erosive esophagitis, a condition associated with GERD, refers to inflammation of the esophagus that may occur after exposure to acidic reflux of stomach contents. For children and adults, symptoms of GERD often include heartburn, regurgitation and upset stomach. Common GERD symptoms in infants include irritability, vomiting, difficulty swallowing, and weight loss or poor weight gain.

"This approval of NEXIUM I.V. for the treatment of children 1 month to 17 years old who are suffering from GERD with erosive esophagitis, gives physicians an important option in the treatment of infants and children," said Marta Illueca, MD, FAAP, executive director of gastrointestinal disorders for AstraZeneca.

"This approval represents an important contribution to an unmet medical need for infants in particular. While some reflux and regurgitation are normal in infants and may not require medical treatment, persistent GERD symptoms can be very uncomfortable and cause damage to the esophagus, just as they can in older patients. Close medical supervision is key in the appropriate diagnosis and choice of treatment for these infants," continued Illueca.

For first-line treatment of pediatric GERD, families are encouraged to try lifestyle modifications, such as smaller, more frequent feedings or dietary changes. If these methods fail, physicians until now have very few approved pharmacological options. NEXIUM I.V. is the first proton pump inhibitor approved for use in infants younger than 1 year old.

NEXIUM I.V. for Injection is an alternative to oral therapy when oral therapy is not possible or appropriate and is administered in the hospital by a health care professional. Treatment with NEXIUM I.V. for more than 10 days has not been studied.




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