Jynarque (jihn-AR’-kew), from Japan’s Otsuka Pharmaceutical, was approved Tuesday for autosomal dominant polycystic kidney disease.
The progressive genetic disorder is the fourth-leading cause of kidney failure. It causes fluid-filled cysts to develop in and damage kidneys.
The FDA rejected it in 2013 but approved it after the drugmaker did an additional study. That one-year study, involving 1,370 patients with advanced disease, found the drug on average slowed kidney function decline about 35 percent more than dummy pills.
Otsuka says the drug, also known as tolvaptan, will cost $13,401 per month without insurance.
Jynarque can cause serious, even fatal liver injury, excessive urination and other side effects.