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FDA Approves AZ's Nexium GERD drug

AstraZeneca announced that its Nexium medication has been approved by the US Food and Drugs Administration for use in children as young as twelve months.

AstraZeneca (AZ) announced that its Nexium medication has been approved by the US Food and Drugs Administration (FDA) for use in children as young as twelve months.

Nexium (esomeprazole magnesium) can now be prescribed for short-term to treat gastroesophageal reflux disease (GERD).

Teenagers aged between 12 to 17-years-old can already be prescribed Nexium, but the FDA approval means preadolescents between the ages of one and 11 can start receiving the drug for the treatment of GERD.

Dr Mark Gilger, chief of service of gastroenterology, hepatology, and nutrition at Texas Children's Hospital, said: "The availability of a proven, effective treatment like Nexium with an established safety profile is an important step in the treatment of this chronic condition."

According to Gilger, GERD is no longer diagnosed only within the adult population, but is now more common than ever amongst children and can cause serious complications such as erosive esophagitis.

GERD causes the stomach contents to be forced back up into the oesophagus and presents symptoms of heartburn and regurgitation.

Dr Marta Illueca, Nexium brand director at AZ, said: "Today's FDA approvals build upon AZ's commitment to better understanding the many patient populations affected by GERD and providing valuable treatment options for each of these groups."

Efficacy and safety data and results regarding the use of Nexium with children under the age of one have yet to be established.

Although Nexium has been proven to heal oesophageal erosions after eight weeks of administration, it can produce adverse side effects including headaches, abdominal pain, and constipation.

Dr Julie Beitz, director of the FDA's Office of Drug Evaluation III in the Centre for Drug Evaluation and Research, said: "Children prescribed this drug should be monitored by their physicians for any adverse drug reactions."

The FDA also approved Nexium for treatment of delayed-release oral suspension with children between one and 11 as a 10mg dosage.

This extended approval could provide grounds for extension of Nexium's patent.

AZ is currently involved in patent litigation over Nexium with Ranbaxy, Teva Pharmaceutical industries and Dr Reddy's Laboratories, all of which are working on generic versions of the drug ahead of expirations of its patent.

29th February 2008

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