Final guidance from the UK’s National Institute for Health and Care Excellence (NICE) recomments Jinarc (tolvaptan) from Japanese drugmaker Otsuka (TYO: 4768) to treat autosomal dominant polycystic kidney disease (ADPKD).
It is the first approved pharmaceutical therapy available in Europe for this indication, which is a chronic and progressive genetic disease causing cyst proliferation and growths in the kidneys. Otsuka says that half of people with this disease will require a kidney transplant or dialysis by the age of 54.
The NICE evaluated data including the Phase III TEMPO 3:4 Trial, the largest study ever undertaken in ADPKD. It took place over a three-year period, and demonstrated a significant reduction of 49% in the annual increase in total kidney volume for tolvaptan-treated patients, versus those in the placebo arm.
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