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| |  AstraZeneca Receives European Approval for Nexium in Paediatric GERD Proton Pump Inhibitor Available For Children Aged 1-11 Years in Sweden LUND, SWEDEN -- November 29, 2007 -- AstraZeneca announced today that it has received Swedish Medical Products Agency (MPA) approval for use of Nexium (esomeprazole) in children aged 1-11 years with gastroesophageal reflux disease (GERD) in the reference member state of Sweden, with other European Union nations expected to follow. Nexium will become the first of the proton pump inhibitors (PPI) currently available for the treatment of pediatric GERD to have a specific formulation developed for children. Children with GERD can experience disruptive symptoms on an everyday basis, with a recent AstaZeneca survey indicating that school performance, sleeping habits and social activities were all affected by the condition. Furthermore, the impact of symptoms can be distressing for not only the child but also their parents and / or caregivers. Nexium, which is licensed for treatment of GERD, will be available in a 10 mg sachet formulation of acid resistant pellets, which are dispersed in liquid. The sachet has a mild citrus-taste and does not contain any artificial flavours. Nexium also provides the added flexibility of administration via nasogastric or gastric tube. In making its recommendations, the MPA reviewed data from a range of safety and pharmacokinetic studies that investigated symptom improvement and healing as secondary endpoints. These included a multicentre parallel group study conducted in 109 children aged 1-11 years with endoscopically proven GERD, of whom almost half had erosive esophagitis. Patients were stratified on the basis of weight and were randomized within each group to receive treatment for 8 weeks (5 or 10 mg esomeprazole < 20kg and 10 or 20 mg [> 20kg]). Patient diary assessments by the parent/guardian showed that among the 58 patients who had moderate to severe symptoms (heartburn, acid regurgitation and epigastric pain) at baseline, over 90% experienced symptomatic improvement after treatment with Nexium. Reflux esophagitis was healed in the majority of patients and Nexium was also shown to be generally well tolerated in the patient population. In children, Nexium is approved for the treatment of GERD patients aged 1-17 years. It is also currently under clinical evaluation for the treatment of GERD in even younger children, aged 0 - 1 year. In adults, Nexium is approved in Europe for the treatment of heartburn and other symptoms associated with acid reflux (GERD), for the treatment of reflux esophagitis and for the long-term management of patients with healed esophagitis to prevent relapse. Nexium is also indicated in the EU for healing of gastric ulcers associated with NSAID therapy and prevention of gastric and duodenal ulcers associated with NSAID therapy in patients at risk. AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of $26.47 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index. For further information, please visit www.astrazeneca.com
SOURCE: AstraZeneca
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