Polycystic kidney disease treatment company The PKD Foundation revealed on Tuesday the receipt of approval from the US Food and Drug Administration (FDA) for JYNARQUE (tolvaptan) as the first treatment for adult patients with rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).

Prior to the US FDA approval, there has been no treatment specifically for PKD in the US. The only treatment options were to receive a transplant or begin dialysis, according to the company. Following this US FDA approval, JYNARQUE will be available in the US for PKD patients in the coming weeks.

ADPKD is the most common form of polycystic kidney disease (PKD), which is one of the most common, life-threatening genetic diseases affecting thousands in America and millions worldwide. It is characterized by uncontrolled growth of cysts in the kidneys and other organs and can lead to kidney failure.

JYNARQUE, which was developed by Otsuka Pharmaceuticals, slows the growth of cysts and the progression of the disease and has been shown to preserve kidney function. The treatment for ADPKD is an oral pill taken twice a day.

The efficacy of JYNARQUE in ADPKD was based on data from two of the company's largest Phase 3 clinical trials in patients with ADPKD. Lasting one and three years respectively, they led to JINARC/JYNARQUE to be approved for adult patients with ADPKD in Japan, the EU, Canada, South Korea, Switzerland, Hong Kong, Australia, Turkey, Taiwan as well as the US.