From NewsWire.ca, News Release
First-ever treatment approved in Canada for adults living with ADPKD, a life-threatening kidney disease
JINARCTM slows the progression of kidney enlargement in patients with autosomal dominant polycystic kidney disease (ADPKD), which should help protect the kidneys from damage and failure
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.1
ADPKD is a chronic and progressive genetic disease, which causes cyst growth in the kidneys, leading to an increase in total kidney volume, resulting in complications that include chronic and acute pain, hypertension and kidney failure.2
ADPKD impacts approximately 35,000 Canadians3 and affects people regardless of gender, age, race or ethnic origin.4
TOKYO, Feb. 26, 2015 /CNW/ - Otsuka Pharmaceutical Co., Ltd. and its affiliate Otsuka Canada Pharmaceutical Inc. announce that Health Canada has approved JINARC™ (tolvaptan) as the first pharmaceutical agent for the treatment of autosomal dominant polycystic kidney disease (ADPKD). JINARC™ is indicated to slow the progression of kidney enlargement by targeting the underlying pathophysiology of the disease.
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, which is the largest, Phase 3 study conducted to date in adults with ADPKD.5
Dr. Sanjay Pandeya, a nephrologist in the Toronto area commented, "Many patients with ADPKD suffer severe pain as the kidneys develop a larger cyst burden. Other organs may also be impacted and kidney failure is a reality in many patients. This can significantly affect overall health and quality of life. The approval of JINARC™ marks a significant advancement in the previously bleak landscape of therapeutics for ADPKD – patients now have an option that can reduce the development of cyst formation, improve symptom control, and potentially delay the progression of this serious disease."
JINARC™ was developed over a period of 26 years through the persevering efforts of researchers in Otsuka's Japanese pharmaceutical research center. Upon discovering a cell signaling pathway that causes renal cysts to proliferate and enlarge,6 Otsuka launched an effort in 2004 to develop a drug for the disease in conjunction with the world's leading ADPKD medical specialists.
ADPKD impacts approximately 35,000 Canadians7 and affects people regardless of gender, age, race or ethnic origin.8 Approximately, half of polycystic kidney disease (PKD) patients reach end stage renal disease (ESRD) and require renal replacement therapy in the form of dialysis or a kidney transplant by age 54.9
"ADPKD is one of the most common, life-threatening, genetic diseases and yet until now, patients have been without a treatment option for the progression of the disease," says Jeff Robertson, Executive Director, PKD Foundation ofCanada. "With a mother and grandmother impacted by ADPKD, our family knows just how life-changing a treatment like this will be for the PKD community."
About the TEMPO 3:4 Trial
The TEMPO 3:4 Trial was conducted over three years in a total of 1,445 adult patients with early, rapidly progressing ADPKD. In order to select patients who might best benefit from the effects of JINARC™, clinical trials evaluated ADPKD patients having enlarged kidneys and relatively preserved renal function at the time of initiation of treatment. In the TEMPO 3:4 Trial, JINARC™ achieved its primary endpoint, demonstrating a statistically significant reduction of almost half (49%) the annual increase in total kidney volume (TKV) versus placebo (p<0.001). Furthermore, the study showed JINARC™ significantly reduced the decline in kidney function by 30% versus placebo (p<0.001).10
The most commonly reported adverse reactions, consistent with the pharmacologic activity of JINARC™ are thirst, polyuria (excessive production of urine), nocturia (waking up during the night in order to urinate), and pollakiuria (frequent daytime urination) occurring in approximately 55%, 38%, 29% and 23% of patients, respectively. In a small percentage of patients receiving JINARC™ (4%) there were adverse events potentially associated with liver injury. As there are no predictive factors as to which patients receiving JINARC™ will experience liver injury, all patients on JINARC™ will be monitored. To help mitigate the risk of liver injury, blood testing for liver enzymes is required prior to initiation of JINARC™, then continuing monthly for 18 months, every 3 months for the next 12 months, and then every 3 to 6 months thereafter during treatment. JINARC™ will only be available through a hepatic safety monitoring and distribution program administrated by Otsuka Canada Pharmaceutical Inc. and managed in conjunction with patients' treating physicians.11
About JINARC™ (tolvaptan)
JINARC™ is a selective vasopressin V2-receptor antagonist and is indicated to slow the progression of kidney enlargement in patients with ADPKD. Vasopressin is a hormone normally responsible for maintaining water balance by stimulating water re-absorption in the kidney. Vasopressin levels are higher than normal in people with ADPKD. The high level of vasopressin promotes cyst growth, which increases the size of the kidneys.12 JINARC™ works by blocking the effects of vasopressin, which can slow down the rate at which cysts – and therefore kidneys – grow. This should help protect kidneys from damage and failure.13 JINARC™, a twice-daily, oral medication,14 is expected to become available to eligible patients in Canada in May 2015. [Read more]
Paying for PKD
Four days a week Tiffanie Woodland inserts a lifeline into her body. The 32-year-old has battled polycystic kidney disease since birth.
"I've had a lot of hospitalizations because of my kidneys, so it's been tough," she says.
"Every pain she has I feel it. and, to see her now on this dialysis machine is really tearing me up," says her mother Michelle Brown.
These three hour sessions could be coming to an end. Tiffanie just found a perfect match for a new kidney. But, she doesn't have $8,000 to cover the medical fees.
She turned to GoFundMe with a plea.
It's hard to know exactly how many crowdfunding sites are on the Internet. Kathy Kristof with Kiplinger's Personal Finance says if you've got a cause or a want, there's likely something to meet your need.
"It's surprising how the community rises to the cause, and sometimes over funds what you've asked for," she says.
Kristof says most sites police themselves for fraud to ensure those donated dollars minus a fee, sometimes as high as nine percent, make it to their intended beneficiary.
Tiffanie's fundraising page has garnered a little over $2,000. She hopes people are moved by her story. And someday soon, she'll get that new working kidney and be able to silence the machine that keeps her alive.
"I just want to be able to move on and enjoy and live my life while I'm still young," she says.
The donations you make on most crowfunding sites are not tax deductible. So, before you contribute to one of these campaigns, evaluate whether your money would go further at an actual charity.
Knowledge is Key to Receiving an Organ Transplant in Canada
On March 1st, Hamiltonians Jessica Gold and Arie Pekar will share true stories of tribulation and triumph on their personal journeys to getting the gift of life.
Hamilton, Canada, February 25, 2015 --(PR.com)-- Jessica Gold's daughter, Alexandria, was only 5 months old when she received a life-saving liver transplant in 2010, thanks to a deceased donor. Jessica has chosen to learn as much as possible about organ and tissue donation, and started a volunteer awareness group to help educate the community of the importance of organ and tissue donation.
“Education is key because not everyone has had a personal encounter with organ donation,” says Gold. “Should the opportunity arise for them or their loved one, I want to make sure they have all the information they need to make the right decision for themselves. Not enough people realize how easy it is to register.”
Arie Pekar also believes research and advocacy is necessary.
“Kidney disease is not a disease for the passive patient,” explains Pekar. “When it comes to organ transplantation, people need to know they have options. Considering other hospitals better suited to meet your choice of treatment does not come naturally to Canadians. We are led to believe treatment options are standardized and they are not.”
Pekar was on dialysis and had recently become a father when a long-time friend gave him the gift of life. With a history of polycystic kidney disease (PKD) in his family, he knows the importance of organ and tissue donation, and how it greatly improved his quality of life and that of his family.
He’ll be sharing the ups and downs en route to his successful kidney transplant for the first time publicly in Classroom B (T2208), in the Juravinski Innovation Tower, St. Joseph's on Charlton Avenue East, after Jessica Gold.
This presentation starting at 2pm is part of an ongoing series of two-hour informational support meetings hosted by the Hamilton Chapter of the PKD Foundation of Canada. They are open to the public free of charge and the venue is wheelchair accessible. Registration is not required. Local street parking (free) and hospital parking (payment required) is available.
For more information about polycystic kidney disease, visit the PKD Foundation of Canada website www.endpkd.ca or call 1-877-410-1741.
"I've had a lot of hospitalizations because of my kidneys, so it's been tough," she says.
"Every pain she has I feel it. and, to see her now on this dialysis machine is really tearing me up," says her mother Michelle Brown.
These three hour sessions could be coming to an end. Tiffanie just found a perfect match for a new kidney. But, she doesn't have $8,000 to cover the medical fees.
She turned to GoFundMe with a plea.
It's hard to know exactly how many crowdfunding sites are on the Internet. Kathy Kristof with Kiplinger's Personal Finance says if you've got a cause or a want, there's likely something to meet your need.
"It's surprising how the community rises to the cause, and sometimes over funds what you've asked for," she says.
Kristof says most sites police themselves for fraud to ensure those donated dollars minus a fee, sometimes as high as nine percent, make it to their intended beneficiary.
Tiffanie's fundraising page has garnered a little over $2,000. She hopes people are moved by her story. And someday soon, she'll get that new working kidney and be able to silence the machine that keeps her alive.
"I just want to be able to move on and enjoy and live my life while I'm still young," she says.
The donations you make on most crowfunding sites are not tax deductible. So, before you contribute to one of these campaigns, evaluate whether your money would go further at an actual charity.
Organ Transplant: Knowledge is Key
From PR.com, Press Release
Hamilton, Canada, February 25, 2015 --(PR.com)-- Jessica Gold's daughter, Alexandria, was only 5 months old when she received a life-saving liver transplant in 2010, thanks to a deceased donor. Jessica has chosen to learn as much as possible about organ and tissue donation, and started a volunteer awareness group to help educate the community of the importance of organ and tissue donation.
“Education is key because not everyone has had a personal encounter with organ donation,” says Gold. “Should the opportunity arise for them or their loved one, I want to make sure they have all the information they need to make the right decision for themselves. Not enough people realize how easy it is to register.”
Arie Pekar also believes research and advocacy is necessary.
“Kidney disease is not a disease for the passive patient,” explains Pekar. “When it comes to organ transplantation, people need to know they have options. Considering other hospitals better suited to meet your choice of treatment does not come naturally to Canadians. We are led to believe treatment options are standardized and they are not.”
Pekar was on dialysis and had recently become a father when a long-time friend gave him the gift of life. With a history of polycystic kidney disease (PKD) in his family, he knows the importance of organ and tissue donation, and how it greatly improved his quality of life and that of his family.
He’ll be sharing the ups and downs en route to his successful kidney transplant for the first time publicly in Classroom B (T2208), in the Juravinski Innovation Tower, St. Joseph's on Charlton Avenue East, after Jessica Gold.
This presentation starting at 2pm is part of an ongoing series of two-hour informational support meetings hosted by the Hamilton Chapter of the PKD Foundation of Canada. They are open to the public free of charge and the venue is wheelchair accessible. Registration is not required. Local street parking (free) and hospital parking (payment required) is available.
For more information about polycystic kidney disease, visit the PKD Foundation of Canada website www.endpkd.ca or call 1-877-410-1741.
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