Sunday, September 2, 2012

Joint Applciation for Approval for Additional Indication for Helicobacter pylori Eradication by Concomitant Therapy with Proton Pump Inhibitors, Amoxicillin Hydrate and either Clarithromycin or Metronidazole

Takeda, AstraZeneca, Mitsubishi Tanabe Pharma Corporation and Eisai have submitted a joint application* to Japan’s Ministry of Health, Labour and Welfare seeking approval of Helicobacter pylori (“H. pylori”) gastritis as an additional indication for H. pylori eradication using concomitant therapy consisting of a proton pump inhibitor, amoxicillin hydrate , and either clarithromycin or metronidazole for treatment of Helicobacter pylori (“H. pylori”) gastritis. H. pylori gastritis is also known as chronic active gastritis due to the fact that it causes histological gastric mucosal injury as a result of the persistent infiltration of inflammatory cells in the gastric mucosa due to H. pylori infection, and is believed to be associated with the development of various H. pylori-related diseases such as gastric and duodenal ulcers. However, under the Japanese National Health Insurance (NHI) system, the approved indications for eradication of H. pylori are currently limited to gastric and duodenal ulcers, gastric MALT lymphoma, idiopathic thrombocytopenic purpura, and the stomach after endoscopic resection of early stage gastric cancer. Against this backdrop, the Japanese Society of Gastroenterology, the Japan Gastroenterological Endoscopy Society and the Japanese Society for Helicobacter Research submitted a letter to the Minister of Health, Labour and Welfare in December 2011 requesting the earliest possible approval and subsequent coverage under NHI of H. pylori gastritis as an additional indication for the eradication of H. pylori by concomitant therapy based on the abundance of clinical evidence already published to date. In response to this, the companies submitted the latest joint application based on the said published evidence in accordance with the "Handling of Ethical Drugs for Off-label Use", Notification No. 4 of the Research and Development Division / Notification No. 104 of the Evaluation and Licensing Division, dated February 1, 1999. The joint applicants of the additional indication also include five other companies marketing amoxicillin hydrate, clarithromycin and metronidazole: Kyowa Hakko Kirin Co., Ltd., Astellas Pharma Inc., ABBOTT JAPAN Co., LTD., Ltd., Shionogi & Co., Ltd. and Taisho Pharmaceutical Co., Ltd.;