Otsuka Pharmaceutical Co., Ltd. and its affiliate Otsuka Canada Pharmaceutical Inc. announce that Health Canada has approved Jinarc (tolvaptan) as the first pharmaceutical agent for the treatment of autosomal dominant polycystic kidney disease (ADPKD). Jinarc is indicated to slow the progression of kidney enlargement by targeting the underlying pathophysiology of the disease.

The Health Canada approval of Jinarc is based on the results of the pivotal Phase 3 randomized, double-blind and placebo-controlled TEMPO 3:4 trial, which is the largest, Phase 3 study conducted to date in adults with ADPKD.

Dr. Sanjay Pandeya, a nephrologist in the Toronto area commented, “Many patients with ADPKD suffer severe pain as the kidneys develop a larger cyst burden. Other organs may also be impacted and kidney failure is a reality in many patients. This can significantly affect overall health and quality of life. The approval of Jinarc marks a significant advancement in the previously bleak landscape of therapeutics for ADPKD – patients now have an option that can reduce the development of cyst formation, improve symptom control, and potentially delay the progression of this serious disease.”

Jinarc was developed over a period of 26 years through the persevering efforts of researchers in Otsuka’s Japanese pharmaceutical research center. Upon discovering a cell signaling pathway that causes renal cysts to proliferate and enlarge,6 Otsuka launched an effort in 2004 to develop a drug for the disease in conjunction with the world’s leading ADPKD medical specialists.

For more details, go to: https://au.finance.yahoo.com/news/first-ever-treatment-approved-canada-210000502.html