SMC approves first ever treatment for genetic kidney disease
pharmafile | January 12, 2016 | News story | Sales and Marketing | Otsuka, SMC, Scottish Medicines Consortium, jinarc, kidney disease, tolvaptan
The Scottish Medicines Consortium (SMC) has approved Otsuka’s Jinarc for the treatment of the genetic kidney disease autosomal dominant polycystic kidney disease (ADPKD).
Jinarc (tolvaptan) is the first medicine to treat the underlying cause of ADPKD and delay its progression, in adults with stage 1-3 chronic kidney disease (CKD) with evidence of rapidly progressing disease. The SMC’s decision follows final guidance from NICE in October 2015, recommending the drug for use in NHS England and the EMA’s approval earlier last year.
ADPKD, the most common inherited kidney disease, is usually characterised by development and enlargement of fluid-filled cysts in the kidneys, leading to an increase in kidney size and further complications including chronic and acute pain, hypertension and eventual kidney failure. About half of people diagnosed with ADPKD progress to end-stage renal disease (ESRD) and require a kidney transplant or dialysis by the age of 54.
“ADPKD has been likened to a ‘ticking time bomb in your belly’ due to its unpredictable nature and devastating impact on families,” says Tess Harris, chief executive of the Polycystic Kidney Disease Charity. “For the first time, we have a treatment that can delay the progression of this disease which brings hope for patients as well as future generations of ADPKD sufferers.”
In making its decision, the SMC considered data from the Phase III TEMPO 3:4 Trial – the largest clinical trial ever undertaken in ADPKD. In this three-year trial, almost half of patients taking Jinarc saw a 2.7% absolute reduction in the annual increase in total kidney volume for compared with those taking placebo.
Jinarc was also shown to reduce the rate of decline in kidney function compared to that of placebo-treated patients by approximately 32%, and Jinarc patients were also 36% less likely to experience clinically significant kidney pain compared to those taking placebo.
Dr Stewart Lambie, consultant in renal and general medicine at the Raigmore Hospital, Inverness, comments: “This is a huge step forward in the management of patients with ADPKD who previously had no specific treatment available to them. It is fantastic news that patients now have access to a treatment that will significantly delay their need for dialysis or a kidney transplant.”
Joel Levy
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