AstraZeneca files Nexium sNDA for infant GERD

Anglo-Swedish drug major AstraZeneca has submitted a supplemental New Drug Application to the US Food and Drug Administration for Nexium  (esomeprazole) to seek approval for the short-term (up to six weeks)  treatment of gastroesophageal reflux disease in pediatric patients aged  up to one year.

GERD is a condition in which the contents of the stomach back up into  the esophagus. Though it is often associated with adults, approximately  seven million children in the USA suffer with it, causing symptoms such  as pain, irritability, constant or sudden crying and frequent vomiting.  Although physiologic, non-painful regurgitation is normal in the first  year of life, a proportion of these infants may have persistent  symptoms diagnosed as GERD that could require treatment with an  acid-suppressive drug to help resolve the problem.

Nexium is a proton pump inhibitor and was approved by the FDA for the  short-term treatment of GERD in adolescents 12 to 17 years old in April  2006, and in children one to 11 years old in February 2008.