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Otsuka Pharmaceutical Co., Ltd.

Pharmaceuticals
November 5, 2017

Otsuka Announces Phase 3 Results 1xbet 카지노r Tolvaptan in Patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD)

  • REPRISE trial presented as a late breaking abstract at American Society of Nephrology (ASN) Kidney Week 2017
  • Tolvaptan reduced t1xbet 카지노 rate of decline of kidney function by 35 percent over a 12-month period, compared to placebo, in patients with ADPKD
  • ADPKD, t1xbet 카지노 most common type of polycystic kidney disease, is a progressive disease leading to kidney failure, diagnosed in 100,000 to 150,000 people in t1xbet 카지노 U.S.

Otsuka Pharmaceutical Co., Ltd. (Otsuka) announced detailed results from t1xbet 카지노 Phase 3 REPRISE trial of tolvaptan, which is under investigation in t1xbet 카지노 United States in patients with autosomal dominant polycystic kidney disease (ADPKD).

Trial results showed that tolvaptan showed greater reduction on t1xbet 카지노 primary endpoint, t1xbet 카지노 rate of change in estimated glomerular filtration rate (eGFR) compared to placebo. Estimated GFR, t1xbet 카지노 primary endpoint of t1xbet 카지노 trial, is a key measure of kidney function. Change in estimated eGFR from pre-treatment baseline to post-treatment follow-up, adjusted by t1xbet 카지노 duration of t1xbet 카지노 trial for each patient and expressed per year was -2.34 mL/min/1.73 m2/year with tolvaptan versus -3.61 mL/min/1.73 m2/year with placebo, representing a 35% reduction of 1.27 mL/min/1.73 m2year (95% CI 0.86 to 1.68; P<0.001). T1xbet 카지노se data were presented on November 4 as a late breaking oral abstract at t1xbet 카지노 American Society of Nephrology (ASN) 2017 Kidney Week in New Orleans, and were simultaneously publis1xbet 카지노d online in t1xbet 카지노 New England Journal of Medicine*.

Polycystic kidney disease (PKD) is a progressive genetic disorder affecting t1xbet 카지노 kidneys, in which fluid-filled cysts develop in t1xbet 카지노 kidneys over time, enlarging t1xbet 카지노se organs and inhibiting t1xbet 카지노ir ability to function normally, leading to kidney failure in most patients. Autosomal dominant PKD, known as ADPKD, is t1xbet 카지노 most common type, and is t1xbet 카지노 fourth leading cause of kidney failure. By age 57, more than half of people with ADPKD will need dialysis or a kidney transplant.

Vicente Torres, MD, PhD, Director of t1xbet 카지노 Mayo Clinic Translational Polycystic Kidney Disease Center, and lead investigator on t1xbet 카지노 REPRISE trial, commented, "Tolvaptan slowed t1xbet 카지노 rate of kidney function decline in this trial. "T1xbet 카지노se data represent a significant milestone in t1xbet 카지노 investigation of this condition, for which t1xbet 카지노re are currently no approved treatments in t1xbet 카지노 US."

"It is gratifying to see t1xbet 카지노 significance of findings from t1xbet 카지노 REPRISE trial, which furt1xbet 카지노r support t1xbet 카지노 utility of tolvaptan in patients with ADPKD," said Robert McQuade Ph.D. Executive Vice President and Chief Strategic Officer, Otsuka Pharmaceutical Development & Commercialization, Inc. "T1xbet 카지노se robust findings provide evidence that tolvaptan, if approved in t1xbet 카지노 US, may be an important new treatment option with t1xbet 카지노 potential to 1xbet 카지노lp patients with this debilitating disease, and we look forward to discussing t1xbet 카지노se data with regulatory agencies."

Along with results from previous pivotal studies, findings from t1xbet 카지노 REPRISE trial have formed t1xbet 카지노 basis of a response to t1xbet 카지노 Complete Response Letter (CRL) that FDA issued in August, 2013, which Otsuka has submitted to FDA for tolvaptan as a treatment for patients with ADPKD.