FDA approves JYNARQUE as the first treatment for ADPKD, autosomal dominant polycystic kidney disease which is the fourth leading cause of end-stage renal disease.
ADPKD is the most common form of polycystic kidney disease (PKD) and there are 600,000 Americans currently suffering from PKD. But the U.S. Food and Drug Administration (FDA) approved the very first treatment for the drug named JYNARQUE (pronounced jin-AR-kew and also known as tolvaptan) for adult patients. The PKD Foundation made the announcement about the grant on April 24.
ADPKD characterized by a painful disorder in which fluid-filled cysts grow in the kidneys and other organs and can even lead to dialysis or kidney transplantation. In the U.S., around 140,000 people are diagnosed with ADPKD.
Before today there has been no specific treatment for PKD except a transplant or dialysis and JYNARQUE for PKD can cause a slower decline in their kidney function, improving health and well-being.
JYNARQUE could be available in four to six weeks and patients who don’t have insurance, the treatment will cost $13,000 for a month.
“Today is a historic day in providing hope to patients with polycystic kidney disease, and we are thrilled to be a part of this first milestone to treat patients with ADPKD,” said CEO of the PKD Foundation, Andy Betts. “For the past 35 years, our goal has been to support PKD patients from care to cure. It is gratifying to play a part in the discovery of this treatment and to see it come to fruition.”