AstraZeneca gets FDA Nexium approval for teens

The FDA has approved the use of Nexium, AstraZeneca’s gastroesophageal drug, in children aged between 12 and 17-years old. The announcement follows a study of 149 children with gastroesophageal reflux disease (GERD, or GORD in the UK), which causes the contents of the stomach to re-enter the oesophagus.

No safety concerns were found during the study and the listed side effects were limited to headaches, nausea, diarrhoea and abdominal pain. AstraZeneca says that eight per cent of American children aged between 12 and 17 suffer from GERD.

Nexium, a proton pump inhibitor, is already approved for use in adults with chronic heartburn and other symptoms associated with GERD. Sales of the drug increased by 16 per cent during the last quarter, according to AstraZeneca’s results released last week.

Marta Illueca, AstraZeneca’s director of medical sciences, gastrointestinal and respiratory, said: “GERD isn?t just a disease that affects adults, it also is common in childhood and can be problematic for adolescents as well.”

She added: “We believe today?s approval is an important step in providing a valuable treatment option for thousands of patients across the country.”

The British Medical Journal estimates that between a quarter and a third of adults suffer some symptoms of GERD, which affects men and women equally, but only a quarter speak to their GPs about it. It said that in 2000, Britons spent over 93 million pounds on over-the-counter treatments for indigestion.

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