Takeda Pharmaceutical Company has announced the approval of Helicobacter pylori Gastritis as an additional indication to eradicate Helicobacter pylori using triple therapy with proton pump inhibitor by Japan's Ministry of Health, Labour and Welfare.
The concomitant therapy contains proton pump inhibitor (lansoprazole, omeprazole, rabeprazole sodium and esomeprazole magnesium hydrate, generic name), amoxicillin hydrate, and either clarithromycin or metronidazole.
H. pylori gastritis, thought to be linked with the development of diseases such as gastric and duodenal ulcers, is a histological gastric mucosal injury caused by the persistent infiltration of inflammatory cells in the gastric mucosa due to H. pylori infection.
In December 2011, the presidents of the Japanese Society of Gastroenterology, the Japan Gastroenterological Endoscopy Society, and the Japanese Society for Helicobacter Research submitted a joint letter to the Minister of Health, Labour and Welfare in requesting the coverage under National Health Insurance of H. pylori gastritis as an additional indication for H. pylori eradication by triple therapy.
Further in August 2012, a joint application was submitted by four companies along with five other companies requesting additional indication approval for each drug.
Four companies believe that the extra indication will aid in preventing and treating H. pylori related diseases.