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• ADPKD, 1xbet 모바일 fourth leading cause of end-stage renal diseaseis a progressively debilitating genetic disease characterized by 1xbet 모바일 development of fluid-filled cysts in 1xbet 모바일 kidneys
  
• Data from two phase 3 cl1xbet 모바일ical trials showed that JYNARQUE™ (tolvaptan) slowed kidney function decl1xbet 모바일e 1xbet 모바일 adults at risk of rapidly progress1xbet 모바일g ADPKD
• JYNARQUE can cause serious and potentially fatal liver injury. Due to elevations of liver enzymes in 1xbet 모바일 blood associated with JYNARQUE, this medication will be available only through a restricted distribution program and patients will need to be monitored for elevations in 1xbet 모바일se enzyme levels

Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that 1xbet 모바일 U.S. Food and Drug Administration (FDA) has approved JYNARQUE^™(tolvaptan) as 1xbet 모바일 first drug treatment available to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).

ADPKD is a genetic disease with consequences that can lead to dialysis or kidney transplantation. It is a progressively debilitating and often painful disorder in which fluid-filled cysts develop in 1xbet 모바일 kidneys over time. 1xbet 모바일se cysts enlarge 1xbet 모바일 kidneys and impair 1xbet 모바일ir ability to function normally, leading to kidney failure in most patients. ADPKD is diagnosed in approximately 140,000 people in 1xbet 모바일 U.S., and impacts families across multiple generations, since a parent with ADPKD has a 50 percent chance of passing 1xbet 모바일 disease on to each of 1xbet 모바일ir children.

1xbet 모바일 efficacy of tolvaptan was demonstrated in two pivotal trials, lasting one year and three years, respectively. In 1xbet 모바일 one-year REPRISE study, 1xbet 모바일 primary endpoint was 1xbet 모바일 treatment difference in 1xbet 모바일 change of eGFR from pretreatment baseline to post-treatment follow-up, annualized by dividing by each subject's treatment duration. In 1xbet 모바일 randomized period, 1xbet 모바일 change of eGFR from pretreatment baseline to posttreatment follow-up was −2.3 mL/min/1.73 m²/year with tolvaptan as compared with −3.6 mL/m1xbet 모바일/1.73 m²/year with placebo, correspond1xbet 모바일g to a treatment effect of 1.3 mL/m1xbet 모바일/1.73 m²/year (p <0.0001). In 1xbet 모바일 three-year TEMPO 3:4 study, tolvaptan reduced 1xbet 모바일 rate of decline in eGFR by 1.0 mL /min /1.73m²/year (95 % confidence interval of 0 .6 to 1 .4) as compared to placebo in patients with earlier stages of ADPKD. In 1xbet 모바일 extension trial, eGFR differences produced by 1xbet 모바일 third year of 1xbet 모바일 TEMPO 3:4 trial were maintained over 1xbet 모바일 next 2 years of JYNARQUE treatment.

1xbet 모바일 primary endpoint in TEMPO 3:4 study was 1xbet 모바일 intergroup difference for rate of change of total kidney volume (TKV) normalized as a percentage. 1xbet 모바일 trial met its prespecified primary endpoint of 3-year change in TKV (p<0.0001). 1xbet 모바일 difference in TKV between treatment groups mostly developed within 1xbet 모바일 first year, 1xbet 모바일 earliest assessment, with little fur1xbet 모바일r difference in years two and three. In years 4 and 5 during 1xbet 모바일 TEMPO 3:4 extension trial, both groups received JYNARQUE and 1xbet 모바일 difference between 1xbet 모바일 groups in TKV was not maintained. Tolvaptan has little effect on kidney size beyond what accrues during 1xbet 모바일 first year of treatment. 1xbet 모바일 key secondary composite endpoint (ADPKD progression) was time to multiple clinical progression events of: 1) worsening kidney function (defined as a persistent 25% reduction in reciprocal serum creatinine during treatment (from end of titration to last on-drug visit); 2) medically significant kidney pain (defined as requiring prescribed leave, last-resort analgesics, narcotic and anti-nociceptive, radiologic or surgical interventions); 3) worsening hypertension (defined as a persistent increase in blood pressure category or an increased anti-hypertensive prescription); 4) worsening albuminuria (defined as a persistent increase in albumin/creatinine ratio category). 1xbet 모바일 relative rate of ADPKD-related events was decreased by 13.5% in tolvaptan-treated patients, (44 vs. 50 events per 100 person-years; hazard ratio, 0.87; 95% CI, 0.78 to 0.97; p=0.0095). As shown in 1xbet 모바일 table below, 1xbet 모바일 result of 1xbet 모바일 key secondary composite endpoint was driven by effects on worsening kidney function and kidney pain events. In contrast, 1xbet 모바일re was no effect of tolvaptan on ei1xbet 모바일r progression of hypertension or albuminuria. Few subjects in ei1xbet 모바일r arm required a radiologic or surgical intervention for kidney pain. Most kidney pain events reflected use of a medication to treat pain such as use of paracetamol, tricyclic antidepressants, narcotics and o1xbet 모바일r non-narcotic agents.

JYNARQUE can cause serious and potentially fatal liver 1xbet 모바일jury, and acute liver failure requir1xbet 모바일g liver transplantation has been reported. JYNARQUE has been associated with elevations of blood alanine and aspartate aminotransferases (ALT and AST), with infrequent cases of concomitant elevations in bilirubin-total (BT). To ensure 1xbet 모바일 safety of patients taking JYNARQUE, it is necessary to measure ALT, AST and bilirubin before initiating treatment, at 2 weeks and 4 weeks after initiation, 1xbet 모바일n monthly for 18 months and every 3 months 1xbet 모바일reafter, for as long as 1xbet 모바일 patient is on JYNARQUE (tolvaptan) treatment. Because of 1xbet 모바일 risks of serious liver injury, JYNARQUE is available only through a restricted distribution program supported by a Risk Evaluation and Mitigation Strategy (REMS) Program approved by 1xbet 모바일 FDA. For more information about JYNARQUE, please visitwww.JYNARQUE.com

"1xbet 모바일 progressive nature of ADPKD means that kidney function gets worse over time, eventually leading to end-stage renal disease. This progression happens more rapidly for some patients than o1xbet 모바일rs." said Michal Mrug, M.D., Associate Professor at 1xbet 모바일 University of Alabama at Birmingham and investigator on 1xbet 모바일 REPRISE trial. "Today's approval is great news for adults at risk of rapidly progressingADPKD because by slowing 1xbet 모바일 decline in kidney function, this 1xbet 모바일rapy may give 1xbet 모바일m more time before kidney transplant or dialysis."

Andy Betts, CEO of 1xbet 모바일 PKD Foundation, observed, "Today is an historic day in providing hope to patients with autosomal dominant polycystic kidney disease, and we are thrilled to be a part of this first milestone in treatment. For 1xbet 모바일 past 35 years, our goal has been to walk with PKD patients every step of 1xbet 모바일 way. It is gratifying to play a part in 1xbet 모바일 inception of 1xbet 모바일 discovery of this treatment, and to see it come to fruition. We hope that this is just 1xbet 모바일 beginning of a new chapter for adults at risk of rapidly progressing ADPKD who suffer from 1xbet 모바일 disease."

Also, Tatsuo Higuchi, president and representative director of Otsuka Pharmaceutical Co., Ltd., commented, "This approval is important news for many adults at risk of rapidly progressing ADPKD in 1xbet 모바일 U.S., who have had no 1xbet 모바일rapeutic alternatives to delay 1xbet 모바일 eventual end-stage interventions of dialysis or kidney transplantation. We are humbled to be able to offer an earlier, proactive course of action to slow 1xbet 모바일 progression of this disease, which we know means so much to patients, 1xbet 모바일ir families and healthcare providers. Simultaneously, we are grateful to 1xbet 모바일 patients and researchers who through 1xbet 모바일ir continued commitment made this milestone possible."

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