Skip to NavigationSkip to content

Otsuka kidney drug earns first NICE nod

Published on 28/10/15 at 10:22am

NICE has released final guidance recommending Otsuka’s Jinarc, the first-ever treatment shown to slow progression of life-threatening Autosomal Dominant Polycystic Kidney Disease (ADPKD), for use in the NHS in England and Wales. 

The drug will be issued to ADPKD adult patients with chronic kidney disease (CKD) at stages 2 or 3 at the start of treatment with evidence of rapidly progressing disease. Jinarc (tolvaptan) is the first disease-modifying treatment available on the NHS, for slowing the progression of cyst development and helping protect renal function. 

The guidance also stipulates that Jinarc can only be prescribed if the company provides the drug at a pre-agreed discounted rate. The NICE final guidance on Jinarc follows its European marketing authorisation, granted in May 2015. 

ADPKD is the most common inherited kidney disease and is primarily characterised by the development and enlargement of multiple fluid-filled cysts in the kidneys which lead to an increase in kidney size and complications that include chronic and acute pain, hypertension and kidney failure. Approximately half of people with ADPKD will require a kidney transplant or dialysis by the age of 54. 

The data evaluated by NICE included the results of the pivotal Phase III TEMPO 3:4 Trial – the largest study ever undertaken in ADPKD. Over a three year period, the study demonstrated a significant reduction of approximately half in the annual increase in total kidney volume for Jinarc-treated patients versus those taking placebo.

Furthermore, Jinarc was shown to reduce the rate of decline in kidney function compared to placebo-treated patients by approximately 32%. Patients taking Jinarc were also less likely to experience clinically significant kidney pain compared to those taking placebo. 

Dr Richard Sandford, a consultant clinical geneticist at Addenbrookes Hospital in Cambridge, says: “For many people with ADPKD, kidney failure at a relatively young age has been a daunting prospect which we’ve been unable to guard against. This NICE recommendation will give us the opportunity to help some patients with ADPKD to reduce the number of symptoms they experience and potentially slow their progression towards kidney failure.” 

Tess Harris, chief executive of the Polycystic Kidney Disease charity says: “ADPKD is the most common, life-threatening genetic kidney disease with an unpredictable and often cruel impact on the families it affects. Until now there has never been a treatment that can delay the progression of ADPKD. Today’s NICE guidance has the potential to fundamentally change the outlook for patients with ADPKD and their families and brings great hope for the future.” 

Yasmita Kumar

Mission Statement is a leading portal for the pharmaceutical industry, providing industry professionals with pharma news, pharma events, pharma service company listings and pharma jobs,
Site content is produced by our editorial team exclusively for and our industry newspaper Pharmafocus. Service company profiles and listings are taken from our pharmaceutical industry directory, Pharmafile, and presented in a unique Find and Compare format to ensure the most relevant matches