Polycystic Kidney Disease (PKD) Support Group
Polycystic kidney disease (PKD) is a progressive, genetic disorder of the kidneys. It occurs in humans and other organisms. PKD is characterised by the presence of multiple cysts (polycystic) in both kidneys. The disease can also damage the liver, pancreas and rarely the heart and brain.
http://www.pkdcure.org/news/treatment-for-adpkd-approved-in-canada
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.
We are very excited for our ADPKD patients in Canada to have access to a treatment that slows the progression of kidney enlargement. For patients in the United States, we are hopeful this is within reach as well. Otsuka Pharmaceutical Development & Commercialization, Inc. and the United States Food & Drug Administration (FDA) have been working together to determine the most appropriate path forward. Initially, in late August of 2013, Otsuka received a Complete Response Letter (CRL) from the FDA regarding tolvaptan to treat adult patients with ADPKD. The FDA issues CRLs to convey that their initial review of a new drug application is complete and they cannot approve it in its present form without additional information.
In June 2014, Otsuka announced that patient enrollment began for a new Phase 3b study of tolvaptan for adult patients with ADPKD. The company reached an agreement with the FDA on a Special Protocol Assessment (SPA) for the design and planned analysis of this trial. This Phase 3b trial is being conducted to provide the additional information requested by the FDA.
Patients play a key role in developing treatments by volunteering to participate in clinical studies. To learn more about getting involved in this and other trials, visit pkdcure.org/research/clinical-studies
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.
We are very excited for our ADPKD patients in Canada to have access to a treatment that slows the progression of kidney enlargement. For patients in the United States, we are hopeful this is within reach as well. Otsuka Pharmaceutical Development & Commercialization, Inc. and the United States Food & Drug Administration (FDA) have been working together to determine the most appropriate path forward. Initially, in late August of 2013, Otsuka received a Complete Response Letter (CRL) from the FDA regarding tolvaptan to treat adult patients with ADPKD. The FDA issues CRLs to convey that their initial review of a new drug application is complete and they cannot approve it in its present form without additional information.
In June 2014, Otsuka announced that patient enrollment began for a new Phase 3b study of tolvaptan for adult patients with ADPKD. The company reached an agreement with the FDA on a Special Protocol Assessment (SPA) for the design and planned analysis of this trial. This Phase 3b trial is being conducted to provide the additional information requested by the FDA.
Patients play a key role in developing treatments by volunteering to participate in clinical studies. To learn more about getting involved in this and other trials, visit pkdcure.org/research/clinical-studies
We both have a blood test once a month to monitor our kidney and liver function. My GFR and function were pretty good until about a year ago when a severe infection caused me to lose a lot of function. My GFR is now at 29. My daughter has almost normal kidney function.
When they increase the dosage of Jinarc you do see a dip in function... but it does come back. I am so grateful to have an opportunity to be on this drug an hopefully slow the progression of my disease.
My insurance covers my drug costs but my daughter does not have insurance and the drug company is covering the costs for her.
I am hoping to move onto the highest dose in a month and if I can tolerate the side effects (which so far have not been that bad). I am very thirsty most of the time but have got used to drinking a lot and going to the bathroom more often. The side effects seem to subside the longer I am on the medication.
I feel that doctors who are reluctant to prescribe this medication are doing their patients a disservice, as there are very few other options out there.
I hope this is helpful to anyone considering taking Jinarc.
I moved to 60/30 dosage. Marked change in overnight urination, but that is about it. Sounds like us in Canada have the best cost options by far at this time. I am thankful for that.
Tolvaptan does increase the sodium in your blood levels, so you get blood tests regularly. Even the heart failure patients taking tolvaptan the USA get monitored frequently.
So it's incorrect to say it isn't approved in the USA. It is, just not for ADPKD- yet.
The reason given for the restriction is that the trials demonstrated effectiveness for this defined population.
Chewitt
If the rate of decline is rather slow, it is difficult to show a very small improvement, justify the cost, etc ... just guessing???
I will just be happy that I have been accepted in the Jinarc system and approved in Canada