On 28 May, 2015, the first-ever drug therapy for adults with ADPKD, was approved in Europe.

JINARC® - the brand name of the drug we know more commonly as tolvaptan - was developed by Otsuka Pharmaceutical Co Ltd. The company was granted marketing authorisation for JINARC® (tolvaptan) based on the findings of the pivotal Phase III randomised, double-blind and placebo-controlled TEMPO 3:4 trial – the largest clinical study conducted in ADPKD to date.

Click here for more information about Tolvaptan.

The European Medicines Agency (EMA) has recommended granting a marketing authorisation to tolvaptan, which now has the brand name: JINARC.

Listen to Dr Donal O'Donoghue, the former National Clinical Director of Kidney Care in England, discuss the Tolvaptan trial and its implications for ADPKD patients. (20 minute video skype chat.)

The Department of Health has asked NICE - the National Institute for Health and Care Excellence - to conduct an appraisal of tolvaptan for treating ADPKD (autosomal dominant polycystic kidney disease). The date of the appraisal meeting will be 1st April 2015.

At the American Society of Nephrology (ASN) meeting on 3 November 2012, Dr Vicente Torrres from the Mayo Clinic, together with research collaborators, reported the results of a 3 year global study known as TEMPO - Tolvaptan Efficacy and Safety in Management of Autosomal Dominant Polycystic Kidney Disease Outcomes.