Otsuka Pharmaceutical Europe Ltd. (OPEL) today announced that the European Commission has approved an extension of indication for JINARC® (tolvaptan) to include adult patients with CKD stage 4 Autosomal Dominant Polycystic Kidney Disease (ADPKD). JINARC® was approved in 2015 for the treatment of ADPKD in adults with CKD stage 1-3 at initiation of treatment and evidence of rapidly progressing disease. The decision to include stage 4 within the JINARC® license comes following the submission of additional data from the REPRISE study that supported the safety and efficacy of this treatment in patients with more advanced renal disease.
Data from the tolvaptan clinical trial program were submitted to the European Commission, including the REPRISE study, which supported the efficacy and tolerability of JINARC® observed in the previous TEMPO 3:4 and TEMPO 4:4 studies. These studies confirmed that tolvaptan slows the progression of ADPKD in patients with earlier (CKD stage 1-3) as well as those with advanced (CKD stage 4) stages of disease.
JINARC® is a selective vasopressin-2-receptor antagonist containing the active substance tolvaptan. It blocks receptors in the kidneys that are responsible for the action of vasopressin. Suppression of vasopressin activity reduces the formation and enlargement of cysts and protects kidney function in patients with polycystic kidney disease (PKD). ADPKD is a progressive genetic disorder affecting the kidneys, in which fluid-filled cysts develop in the kidneys over time, enlarging these organs and reducing their ability to function normally, leading to kidney failure in most patients. ADPKD is the most common type of PKD, and is the fourth leading cause of kidney failure. Approximately 70% of European patients with ADPKD progress to end-stage renal disease (ESRD) at a median age of 58 years.
JINARC® is the only pharmacological treatment indicated to slow the progression of cyst development and renal insufficiency in ADPKD patients with evidence of rapidly progressing disease.