The European Medicines Agency (EMA) has recommended granting a marketing authorisation to 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.

ADPKD affects approximately 4 in 10,000 people in the European Union (EU). It is an inherited condition marked by the growth of numerous fluid-filled cysts in the kidneys and other organs. The growth of cysts eventually affects kidney function and can cause the kidneys to fail. Symptoms include abdominal pain, problems with urinating, high blood pressure and infection.

No medicine is specifically authorised in the EU to treat patients with ADPKD. Current treatment focuses on the treatment of symptoms and complications. There is therefore a clear unmet need for an effective therapy for ADPKD.

Tolvaptan, a vasopressin-2-receptor antagonist, is already authorised in the EU for treating hyponatraemia (abnormally low sodium levels) although the doses studied in ADPKD are different.

For more details, go to: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/02/news_detail_002280.jsp&mid=WC0b01ac058004d5c1