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Broad European Approval for Nexium, the First PPI Developed as an Isomer
Article
NEWS FROM THE INDUSTRY
AstraZeneca
During 2000, AstraZeneca received broad approval across European Union member states for Nexium (esomeprazole), the first PPI developed as an isomer. Nexium is approved for management across the spectrum of gastroesophageal reflux disease (GERD) including:
- Treatment of erosive reflux esophagitis.
- Long term management of patients with healed reflux esophagitis to prevent relapse.
- Symptomatic treatment of GERD.
Additionally, in combination with an appropriate antibiotic regimen, Nexium is approved for the eradication of H. pylori for:
- Healing of H. pylori-associated duodenal ulcer.
- Prevention of relapse of peptic ulcers in patients with H. pylori-associated ulcers.
An evolution in PPI therapy
AstraZeneca has committed over three decades of leading research to advancing the treatment of gastrointestinal disease. The PPI class was born with the invention of timoprazole by AstraZeneca in 1974, leading to the development of Losec (omeprazole) which set a new standard in the management of acid related diseases. Now, studies with Nexium in over 12,000 patients, in 670 centres and 20 countries, demonstrate that Nexium represents a further evolution in PPI therapy beyond omeprazole and the other PPIs that have followed.
Enhanced clinical efficacy and new approaches to patient management
The underlying rationale for the superiority of Nexium is its advantageous metabolism compared with omeprazole which results in enhanced delivery of Nexium to the proton pump. Consequently, acid control with Nexium is greater, faster and more sustained than with other PPIs, and this superiority of acid control with Nexium has been shown to result in improved clinical efficacy and predictability compared with omeprazole. Nexium:
- Heals reflux esophagitis in more patients in a shorter period of time compared with omeprazole.
- Achieves faster symptom resolution and sustained freedom from GERD symptoms in more patients compared with omeprazole.
- Provides highly effective maintenance therapy for reflux esophagitis.
- Is the first PPI to be documented and approved for the new approach of on demand treatment, which patients can take when need, for the long term management of GERD without esophagitis.
- Is the first PPI to be thoroughly documented and broadly approved for the healing of H. pylori-associated duodenal ulcer using 1 week triple therapy without follow up monotherapy.
AstraZenecas ongoing commitment to gastroenterology
In addition to Losec and Nexium, AstraZeneca has a portfolio of products for the management of inflammatory bowel disease. This is only the beginning though, as AstraZeneca has a comprehensive, long term research commitment to gastroenterology. Nexium is the latest result of this, and further innovative products are in the pipeline.
Back to Nexium and Proton Pump Inhibitors Articles
References:
www.omge.org/publications/archive/2000_2/astrazen.htm
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