01 June 2012 | News | By BioSpectrum Bureau
Eisai seeks nod for new Helicobacter Pylori eradication packs
Eisai is seeking approval for two types of new triple formulation packs
Singapore: Eisai, which has its headquarters in Tokyo, has submitted a marketing authorization application to Japan's Ministry of Health, Labor and Welfare for approval of two types of new triple formulation packs (combination packs) for Helicobacter Pylori eradication.
The packs include the company's proton pump inhibitor Pariet (rabeprazole sodium) and amoxicillin hydrate (generic name) and either clarithromycin (generic name) for primary eradication or metronidazole (generic name) for secondary eradication.
Pariet was approved in Japan in January 2007 for adjunctive use with amoxicillin hydrate and clarithromycin in the primary eradication of Helicobacter Pylori infections associated with gastric and duodenal ulcers. In August of the same year, the agent was also approved for secondary eradication, in combination with amoxicillin and metronidazole, in patients for whom primary eradication therapy has been unsuccessful. Additionally, the eradication therapy indication for Pariet was expanded in June 2010 to include gastric MALT lymphoma, idiopathic thrombocytopenic purpura, and the stomach after endoscopic resection of early stage gastric cancer.
Eisai has developed the new triple formulation pack for primary and secondary eradication that includes three separate formulations in a single package in order to help ensure that eradication therapy will be carried out more appropriately and with greater certainty, improve patient drug compliance and offer increased levels of convenience in the medical setting.