TAKECAB Granted Approval for the Treatment of Acid-related Diseases in Japan

TAKECAB Granted Approval for the Treatment of Acid-related Diseases in Japan

In Japan, a new drug called TAKECAB® (Vonoprazan Fumarate) for the treatment of aIBD Overviewcid-related diseases was granted approval from the Japanese Ministry of Health, Labour and Welfare.

The companies Takeda Pharmaceutical Company Limited and Otsuka Pharmaceutical Company, Limited signed an agreement in March 2014 to co-promote the drug in Japan.

Based on the agreement, Takeda will manufacture and market TAKECAB, and Takeda and Otsuka will inform healthcare professionals of the new drug in order to meet clinical needs in the treatment of acid-related diseases. Takeda will receive a milestone payment for the NDA approval. Otsuka will receive co-promotion fee based on sales amounts from Takeda.

The new drug TAKECAB was developed by Takeda and has a mechanism of action called potassium-competitive acid blockers (P-CABs) that prevents the binding of potassium ions to H+,K+ -ATPase in the final step of gastric acid secretion in gastric parietal cells. TAKECAB provides a prolonged acid secretion inhibitory effect.

The results from Phase III clinical trials with TAKECAB for gastric ulcer, duodenal ulcer, erosive esophagitis and H. pylori eradication in Japan were pivotal for this approval. These trials revealed that TAKECAB is effective, safe and well-tolerable in the treatment of these conditions.

TAKECAB is indicated for the treatment of gastric ulcers, duodenal ulcers, erosive esophagitis, prevention of recurrence of gastric or duodenal ulcer during low-dose aspirin administration, prevention of recurrence of gastric or duodenal ulcer during non-steroidal anti-inflammatory drug (NSAID) administration. Moreover, the drug is effective when used as an adjuvant with Helicobacter pylori eradication in gastric ulcer, duodenal ulcer, gastric mucosa-associated lymphatic tissue (MALT) lymphoma, idiopathic thrombocytopenic purpura, the stomach after endoscopic resection of early stage gastric cancer, or Helicobacter pylori gastritis.

Otsuka Pharmaceutical Company, Limited, is a global healthcare company that researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for the maintenance of everyday health.

Takeda Pharmaceutical Company Limited is the largest pharmaceutical research-based in Japan and is one of the global leaders in the industry.