Canada becomes the first country outside Japan to approve JinarcTM (Tolvaptan) for the treatment of ADPKD. This medication, dosed twice daily, is the first of its kind to show a slowing in renal function decline as well as a slowing in kidney enlargement among patients with ADPKD.
The approval of Jinarc follows the landmark TEMPO 3:4 Study which randomized 1445 patients to receive a mean dose of 95 mg of Tolvaptan versus placebo over a 3 year period of observation. Patients receiving active drug experienced a slowing in growth of ADPKD kidney volume by 50% and also a slower deterioration in GFR, the primary and secondary outcomes of the study respectively. While there was a greater number of adverse effects related to the medication (polyuria, thirst, hyperuricemia, gout, hepatitis, hypernatremia), there were less ADPKD-related effects (pain, hemturia, urinary tract infection).
It still remains to be seen which patients with this disorder would stand to benefit most from this medication, nevertheless, Jinarc's approval represents an very exciting breakthrough for patients with ADPKD in Canada, and hopefully soon, those in the rest of the world.
View UKidney's Autosomal Dominant Polycystic Kidney Disease (ADPKD) Wall of Experts by clicking here. Part 2 is coming soon with a special focus on Tolvaptan in ADPKD.