FDA OK's AstraZeneca's Nexium for kids

WILMINGTON, Del., May 1 (UPI) -- AstraZeneca said Monday the Food and Drug Administration OK'd the use of Nexium in adolescents with gastroesophageal reflux disease.

The FDA approval is for the short-term treatment of GERD in children ages 12 to 17. AstraZeneca said there are about 3 million kids in this age range in the United States that suffer from GERD.

"GERD isn't just a disease that affects adults, it also is common in childhood and can be problematic for adolescents as well," said Marta Illueca of AstraZeneca. "We believe today's approval is an important step in providing a valuable treatment option for thousands of patients across the country."

The approval was supported by a multi-center trial involving 149 GERD patients, ages 12 to 17, who received either Nexium 20 mg or Nexium 40 mg once daily for up to eight weeks. Additional data came from safety and pharmacokinetics studies in adolescents and extrapolation of results from adult studies.