LONDON--(BUSINESS WIRE)--AstraZeneca announced today that it has completed the Mutual Recognition Procedure in Europe with Sweden as Reference Member State for the use of Nexium® (esomeprazole) to prevent peptic ulcer re-bleeding in adults.1
Esomeprazole i.v. is the first proton pump inhibitor (PPI) to be indicated in Europe for prevention of re-bleeding following therapeutic endoscopy for acute bleeding gastric or duodenal ulcers. The i.v. treatment should be followed by oral acid suppression therapy. Esomeprazole oral also received the indication for prolonged treatment after i.v. induced prevention of re-bleeding peptic ulcers. National approvals will follow throughout 2009.
“Peptic ulcer bleed (PUB) is a common and potentially life-threatening complication of peptic ulcer disease and until now there has not been an approved pharmacological treatment to reduce the risk of re-bleeding after endoscopic treatment, the current standard treatment for bleeding peptic ulcers with high risk for re-bleeding. Currently, approximately 20% of patients with PUB may experience a re-bleed even after endoscopic treatment2,3 and patients experiencing re-bleeding after initial treatment of PUB have a more than three-fold risk of death.3 The approval of Nexium® for preventing peptic ulcer re-bleeding in adults fills a significant gap in current treatment options available to physicians to manage PUB after endoscopic treatment,” said Professor Ernst Kuipers of The Erasmus Medical Centre, Rotterdam.
The licence application was based on the findings from a large, multinational, randomised, double-blind, placebo-controlled study that was conducted in 16 countries across Europe, Asia and Africa.4 The study population consisted of 767 patients, male and female, aged 18 years or over, who had undergone successful endoscopic haemostatic treatment for PUB. The patients received high doses of i.v. therapy of esomeprazole (80mg intravenous bolus infusion for 30 minutes followed by esomeprazole 8mg per hour i.v. for 71.5 hours) or matching placebo infusion for 72 hours.4 All patients then additionally received once-daily oral esomeprazole 40mg for 27 days.4
Overall, the study showed that esomeprazole significantly reduced the number of patients having a re-bleed after initial endoscopic haemostatic treatment of PUB by almost half. The treatment was found to be more effective within 3, 7, and 30 days in reducing re-bleeding4 and reduced the use of hospital resource compared with placebo.5 Esomeprazole was also considered to be generally well tolerated.6
Until now, no other PPI has demonstrated an overall benefit in high risk peptic ulcer bleeding patients in published international, multi-center studies of PUB in predominantly Caucasian patient populations. 7-12
Esomeprazole is already approved in Europe for the treatment of gastroesophageal reflux disease (GORD), for the treatment of reflux esophagitis (RO) and for the long-term management of patients with healed esophagitis to prevent relapse. Esomeprazole is also indicated in the Europe for healing of gastric ulcers associated with NSAID therapy and prevention of gastric and duodenal ulcers associated with NSAID therapy in patients at risk.1 Esomeprazole in combination with an appropriate antibacterial therapeutic regimen is also approved for the eradication of H. pylori and the healing of H. pylori associated duodenal ulcer and the prevention of relapse of peptic ulcers in patients with H. pylori associated ulcers. Esomeprazole i.v. 40 mg powder for injection/infusion as a solution is approved in Europe for gastric antisecretory treatment when the oral route is not possible.
AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of prescription medicines and supplier for healthcare services. AstraZeneca is one of the world’s leading pharmaceutical companies with healthcare sales of US$ 31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. For more information about AstraZeneca, please visit: www.astrazeneca.com
Contact:
AstraZeneca Susanne Björklund +46 (0) 31 706 54 88 (direct) +46 (0) 702061561 (mobile) or Hill & Knowlton (UK) Ltd Simon Grist +44 (0)207 413 3081 (direct) +44(0)7818 037 481(mobile)
