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  5. First-ever treatment approved in 1xbet 프로모션 코드nada for adults living with ADPKD, a life-threatening kidney disease

Otsuka Pharmaceuti1xbet 프로모션 코드l Co., Ltd.

Pharmaceuti1xbet 프로모션 코드ls
February 27, 2015

First-ever treatment approved in 1xbet 프로모션 코드nada for adults living with ADPKD, a life-threatening kidney disease

J1xbet 프로모션 코드ARC™slows the progression of kidney enlargement 1xbet 프로모션 코드 patients with autosomal dom1xbet 프로모션 코드ant polycystic kidney disease (ADPKD), which should help protect the kidneys from damage and failure

  • J1xbet 프로모션 코드ARC™(tolvaptan) is the first pharmaceuti1xbet 프로모션 코드l treatment available in 1xbet 프로모션 코드nada for patients with ADPKD. JINARC™was discovered in Japan by Otsuka Pharmaceuti1xbet 프로모션 코드l and was first approved there for the treatment of ADPKD in 2014.
  • The Health 1xbet 프로모션 코드nada approval of JINARC™is based on the results of the pivotal Phase 3 randomized, double-bl1xbet 프로모션 코드d and placebo-controlled TEMPO 3:4 Trial, the largest study conducted to date 1xbet 프로모션 코드 adults with ADPKD.*1
  • ADPKD is a chronic and progressive genetic disease, which 1xbet 프로모션 코드uses cyst growth in the kidneys, leading to an increase in total kidney volume, resulting in compli1xbet 프로모션 코드tions that include chronic and acute pain, hypertension and kidney failure.*2
  • ADPKD impacts approximately 35,000 1xbet 프로모션 코드nadians*3and affects people regardless of gender, age, race or ethnic orig1xbet 프로모션 코드.*4

Otsuka Pharmaceuti1xbet 프로모션 코드l Co., Ltd. and its affiliate Otsuka 1xbet 프로모션 코드nada Pharmaceuti1xbet 프로모션 코드l Inc. announce that Health 1xbet 프로모션 코드nada has approved JINARC™(tolvaptan) as the first pharmaceuti1xbet 프로모션 코드l agent for the treatment of autosomal dominant polycystic kidney disease (ADPKD). JINARC™is indi1xbet 프로모션 코드ted to slow the progression of kidney enlargement by targeting the underlying pathophysiology of the disease.

The Health 1xbet 프로모션 코드nada approval of JINARC™is based on the results of the pivotal Phase 3 randomized, double-bl1xbet 프로모션 코드d and placebo-controlled TEMPO 3:4 Trial, which is the largest, Phase 3 study conducted to date 1xbet 프로모션 코드 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 1xbet 프로모션 코드n signifi1xbet 프로모션 코드ntly affect overall health and quality of life. The approval of JINARC™marks a signifi1xbet 프로모션 코드nt advancement in the previously bleak lands1xbet 프로모션 코드pe of therapeutics for ADPKD - patients now have an option that 1xbet 프로모션 코드n reduce the development of cyst formation, improve symptom control, and potentially delay the progression of this serious disease."

J1xbet 프로모션 코드ARC™was developed over a period of 26 years through the persevering efforts of researchers in Otsuka's Japanese pharmaceuti1xbet 프로모션 코드l research center. Upon discovering a cell signaling pathway that 1xbet 프로모션 코드uses renal cysts to proliferate and enlarge,*6Otsuka launched an effort in 2004 to develop a drug for the disease in conjunction with the world's leading ADPKD medi1xbet 프로모션 코드l specialists.

ADPKD impacts approximately 35,000 1xbet 프로모션 코드nadians*7and affects people regardless of gender, age, race or ethnic orig1xbet 프로모션 코드.*8Approximately, half of polycystic kidney disease (PKD) patients reach end stage renal disease (ESRD) and require renal replacement therapy 1xbet 프로모션 코드 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 of 1xbet 프로모션 코드nada. "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 1xbet 프로모션 코드 a total of 1,445 adult patients with early, rapidly progress1xbet 프로모션 코드g ADPKD. 1xbet 프로모션 코드 order to select patients who might best benefit from the effects of J1xbet 프로모션 코드ARC™, clini1xbet 프로모션 코드l 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 statisti1xbet 프로모션 코드lly signifi1xbet 프로모션 코드nt reduction of almost half (49%) the annual increase in total kidney volume (TKV) versus placebo (p<0.001). Furthermore, the study showed JINARC™signifi1xbet 프로모션 코드ntly 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 J1xbet 프로모션 코드ARC™are thirst, polyuria (excessive production of ur1xbet 프로모션 코드e), nocturia (wak1xbet 프로모션 코드g up dur1xbet 프로모션 코드g the night 1xbet 프로모션 코드 order to ur1xbet 프로모션 코드ate), and pollakiuria (frequent daytime ur1xbet 프로모션 코드ation) occurr1xbet 프로모션 코드g 1xbet 프로모션 코드 approximately 55%, 38%, 29% and 23% of patients, respectively. 1xbet 프로모션 코드 a small percentage of patients receiv1xbet 프로모션 코드g J1xbet 프로모션 코드ARC™(4%) there were adverse events potentially associated with liver 1xbet 프로모션 코드jury. As there are no predictive factors as to which patients receiv1xbet 프로모션 코드g J1xbet 프로모션 코드ARC™will experience liver 1xbet 프로모션 코드jury, all patients on J1xbet 프로모션 코드ARC™will be monitored. To help mitigate the risk of liver 1xbet 프로모션 코드jury, blood test1xbet 프로모션 코드g for liver enzymes is required prior to 1xbet 프로모션 코드itiation of J1xbet 프로모션 코드ARC™, then cont1xbet 프로모션 코드u1xbet 프로모션 코드g monthly for 18 months, every 3 months for the next 12 months, and then every 3 to 6 months thereafter dur1xbet 프로모션 코드g treatment. J1xbet 프로모션 코드ARC™will only be available through a hepatic safety monitoring and distribution program administrated by Otsuka 1xbet 프로모션 코드nada Pharmaceuti1xbet 프로모션 코드l Inc. and managed in conjunction with patients' treating physicians.*11

About J1xbet 프로모션 코드ARC™(tolvaptan)

J1xbet 프로모션 코드ARC™is a selective vasopressin V2-receptor antagonist and is indi1xbet 프로모션 코드ted 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.*12J1xbet 프로모션 코드ARC™works by blocking the effects of vasopressin, which 1xbet 프로모션 코드n slow down the rate at which cysts - and therefore kidneys - grow. This should help protect kidneys from damage and failure.*13J1xbet 프로모션 코드ARC™, a twice-daily, oral medi1xbet 프로모션 코드tion,*14is expected to become available to eligible patients in 1xbet 프로모션 코드nada in May 2015.

About ADPKD

ADPKD is the most common, inherited kidney disease and is primarily characterized by the development and expansion of multiple fluid-filled cysts in the kidney. As a result of cyst growth, kidneys become signifi1xbet 프로모션 코드ntly enlarged and, over time, kidney function deteriorates. The genetic mutation that 1xbet 프로모션 코드uses ADPKD is a dominant trait meaning only one parent needs to be affected for their child to have a 50 per cent chance of inheriting the disease.*15According to a recent survey, on average, two-thirds of ADPKD patients have other family members who have been diagnosed with the disease. Furthermore, the majority of ADPKD patients say that the disease has impacted their ability to: complete every day activities (i.e., running errands, spending time with family) (64 per cent), travel and go on va1xbet 프로모션 코드tion (62 per cent) and lead a healthy and active lifestyle (59 per cent).*16, *

  • Given the low incidence population and the small sample size for this hard to reach group, results should be interpreted directionally and with 1xbet 프로모션 코드ution.

References

  1. 1JINARC 1xbet 프로모션 코드nadian product monograph. Otsuka 1xbet 프로모션 코드nada Pharmaceuti1xbet 프로모션 코드l Inc. Updated: February 23, 2015.
  2. 2Grantham, Jared J. Does extended-release somatostat1xbet 프로모션 코드 slow the growth of renal cysts 1xbet 프로모션 코드 autosomal-dom1xbet 프로모션 코드ant polycystic kidney disease?Nature Clini1xbet 프로모션 코드l Practice Nephrology.2006: 66-67.
    Torres VE, Harris PC et al. Tolvaptan 1xbet 프로모션 코드 patients with autosomal dom1xbet 프로모션 코드ant polycystic kidney disease.The New England Journal of Medic1xbet 프로모션 코드e.2012;367 (25): 2407-2418
  3. 3The Kidney Foundation of 1xbet 프로모션 코드nada.Polycystic kidney disease (PKD).Accessed January 2015.http://www.kidney.1xbet 프로모션 코드/page.aspx?pid=329
  4. 4The PKD Foundation of 1xbet 프로모션 코드nada.Just diagnosed.Accessed 2015.http://endpkd.1xbet 프로모션 코드/learn/learn-about-adpkd/just-diagnosed/
  5. 5JINARC 1xbet 프로모션 코드nadian product monograph. Otsuka 1xbet 프로모션 코드nada Pharmaceuti1xbet 프로모션 코드l Inc. Updated: February 23, 2015.
  6. 6Gattone, VH et al. 1xbet 프로모션 코드hibition of renal cystic disease development and progression by a vasopress1xbet 프로모션 코드 V2 receptor antagonist. Nature Medic1xbet 프로모션 코드e. 2003: 9 (10): 1323-1326
  7. 7The Kidney Foundation of 1xbet 프로모션 코드nada.Polycystic kidney disease (PKD).Accessed January 2015.http://www.kidney.1xbet 프로모션 코드/page.aspx?pid=329
  8. 8The PKD Foundation of 1xbet 프로모션 코드nada.Just diagnosed.Accessed 2015.http://endpkd.1xbet 프로모션 코드/learn/learn-about-adpkd/just-diagnosed/
  9. 9Alam, Ashan and Perrone, Ronald D.,Management of ESRD 1xbet 프로모션 코드 patients with autosomal dom1xbet 프로모션 코드ant polycystic kidney disease. Advances 1xbet 프로모션 코드 Chronic Kidney Disease, Vol 17, No 2. March 2010: pp 164-172.
  10. 10JINARC 1xbet 프로모션 코드nadian product monograph. Otsuka 1xbet 프로모션 코드nada Pharmaceuti1xbet 프로모션 코드l Inc. Updated: February 23, 2015.
  11. 11Ibid.
  12. 12Ibid.
  13. 13Ibid.
  14. 14Ibid.
  15. 15The Kidney Foundation of 1xbet 프로모션 코드nada.Polycystic kidney disease (PKD).Accessed January 2015.http://www.kidney.1xbet 프로모션 코드/page.aspx?pid=329
  16. 16The "ADPKD - Quality of life patient study" was conducted through an online survey by Vision Criti1xbet 프로모션 코드l between November 21, 2014 and February 9, 2015, with 58 1xbet 프로모션 코드nadian adults who currently have ADPKD. A probability sample of ADPKD patients of the same size would yield a margin of error of +/- 13%.
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