EMA Recommends Otsuka’s Jinarc
The European Medicines Agency (EMA) has recommended granting a marketing authorization to Otsuka Pharmaceutical’s Jinarc (tolvaptan). Jinarc is indicated to slow the progression of cyst development and failing kidney function in adult patients with autosomal dominant polycystic kidney disease (ADPKD). Jinarc is for use in patients with normal to moderately reduced kidney function who have rapidly progressing ADPKD.
No medicine is specifically authorized in the EU to treat patients with ADPKD. Current treatment focuses on the treatment of symptoms and complications. Tolvaptan, a vasopressin-2-receptor antagonist, is already authorized in the European Union (EU) for treating hyponatraemia (abnormally low sodium levels) although the doses studied in ADPKD are different. Otsuka received EU approval for tolvaptan in 2009 under the trade name Samsca for treating adult patients with hyponatraemia secondary to syndrome of inappropriate antidiuretic hormone secretion.
Tolvaptan acts by blocking receptors in the kidneys to which the hormone vasopressin attaches, which regulates the level of water and sodium in the body. In ADPKD, it is thought that kidney cells do not respond normally to vasopressin, leading to the formation of fluid-filled cysts. By blocking vasopressin receptors in the kidneys, Jinarc can slow down cyst formation.
Jinarc was designated as an orphan medicine by the EMA. The CHMP opinion for approval will be sent to the European Commission for the adoption of a decision on EU-wide marketing authorization. Once a marketing authorization has been granted, a decision about price and reimbursement will then take place at the level of each EU member state considering the potential role/use of this medicine in the context of the national health system of that country.