💊Otsuka’s JYNARQUE™ Approved by U.S. FDA as the First Treatment to Slow Kidney Function Decline in Adults at Risk of Rapidly Progressing Autosomal Dominant Polycystic Kidney Disease (ADPKD)

By FDA, Pharmaceutical

💊Otsuka’s JYNARQUE™ Approved by U.S. FDA as the First Treatment to Slow Kidney Function Decline in Adults at Risk of Rapidly Progressing Autosomal Dominant Polycystic Kidney Disease (ADPKD)

  1. ADPKD, the fourth leading cause of end-stage renal disease is a progressively debilitating genetic disease characterized by the development of fluid-filled cysts in the kidneys
  2. Data from two phase 3 clinical trials showed that JYNARQUE™ (tolvaptan) slowed kidney function decline in adults at risk of rapidly progressing ADPKD
  3. JYNARQUE can cause serious and potentially fatal liver injury. Due to elevations of liver enzymes in the blood associated with JYNARQUE, this medication will be available only through a restricted distribution program and patients will need to be monitored for elevations in these enzyme levels

https://www.otsuka.co.jp/company/newsreleases/2018/20180425_1.html

Otsuka drug first to get U.S. FDA approval for most common inherited kidney disease | The Japan Times

https://www.japantimes.co.jp/?post_type=news&p=1399187

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