Otsuka announced that the Food and Drug Administration (FDA) has approved Jynarque (tolvaptan) to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).
Jynarque, a selective vasopressin V2-receptor antagonist, is the first treatment approved for this indication. The efficacy of Jynarque was demonstrated in two trials: REPRISE (Replicating Evidence of Preserved Renal Function: an Investigation of Tolvaptan Safety and Efficacy in ADPKD) and TEMPO 3:4 (Tolvaptan Efficacy and Safety in Management of Autosomal Dominant Polycystic Kidney Disease and Its Outcomes).
REPRISE was a 1-year study that evaluated the treatment difference in the change of eGFR from pre-treatment baseline to post-treatment follow-up. Treatment with tolvaptan led to a change in eGFR of -2.3mL/min/1.73m2/year vs -3.6mL/min/1.73m2/year with placebo (treatment effect 1.3mL/min/1.73m2/year; P <.0001).
TEMPO 3:4 was a 3-year study that evaluated the intergroup difference for rate of change in total kidney volume (TKV) normalized as a percentage. Results showed that the trial met its primary endpoint of 3-year change in TKV (P <.0001). The relative rate of ADPKD-related events was decreased by 13.5% in the tolvaptan-treated patients, (44 vs. 50 events per 100 person-years; hazard ratio, 0.87; 95% CI, 0.78 to 0.97; P=.0095)
“The progressive nature of ADPKD means that kidney function gets worse over time, eventually leading to end-stage renal disease. This progression happens more rapidly for some patients than others.” said Michal Mrug, M.D., Associate Professor at the University of Alabama at Birmingham and investigator on the REPRISE trial. “Today’s approval is great news for adults at risk of rapidly progressing ADPKD because by slowing the decline in kidney function, this therapy may give them more time before kidney transplant or dialysis.”
Due to the risks of serious and potentially fatal liver injury, Jynarque will be available only through a restricted distribution program supported by a Risk Evaluation and Mitigation Strategy (REMS) Program.
Jynarque will be supplied as 15mg, 30mg, 45mg, 60mg, and 90mg strength tablets in 7-day and 28-day treatment packs.
For more information call (800) 438-9927 or visit Jynarque.com.