Feb. 27, 2015
Otsuka Pharmaceutical Co., Ltd. announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended JINARC® (tolvaptan) for approval. This treatment has been recommended to slow the progression of cyst development and renal insufficiency of autosomal dominant polycystic kidney disease (ADPKD) in adults with chronic kidney disease (CKD) stage 1 to 3 at initiation of treatment with evidence of rapidly progressing disease.
Read the full press release from Otsuka Pharmaceutical Co., Ltd.
Feb. 26, 2015
JINARC™ (tolvaptan) has been approved in Canada as a treatment for autosomal dominant polycystic kidney disease (ADPKD). JINARC™ was discovered in Japan by Otsuka Pharmaceutical and was first approved there for ADPKD in 2014. The Health Canada approval of JINARC™ is based on the results of the pivotal Phase 3 randomized, double-blind and placebo-controlled TEMPO 3:4 Trial, the largest study conducted to date in adults with ADPKD.
Voices of PKD
Five years ago, at age 13, I was diagnosed with polycystic kidney disease (PKD) after a series of visits to the emergency room with severe abdominal pain and vomiting. PKD, which causes cysts to grow on the kidneys, eventually leads to kidney failure and can cause a kidney to weigh up to 30 pounds. I am the youngest person in my family to be diagnosed. PKD is a genetic disease and parents with PKD have a 50 percent chance of passing the disease to each of their children. My mother, grandfather and great grandfather all have PKD.
Not only did I find out I had a genetic disease with no treatment or cure, I also had to learn it was a disease that despite affecting thousands in the U.S. and millions world wide had many unknowns and inconsistencies. While as a young teenager all I wanted to do was ignore this imperfection I realized that because I was diagnosed at such a young age, I had the opportunity to help. Unwilling to accept the feeling of powerlessness when facing PKD my mom and I turned to The PKD Foundation, an organization solely dedicated to finding treatments and a cure for PKD, to get involved in a brighter future for the disease.