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• ADPKD, t1xbet 모바일 fourth leading cause of end-stage renal disease is a progressively debilitating genetic disease characterized by t1xbet 모바일 development of fluid-filled cysts in t1xbet 모바일 kidneys
  
• Data from two phase 3 clini1xbet 모바일l trials showed that JYNARQUE™ (tolvaptan) slowed kidney function decline in adults at risk of rapidly progressing ADPKD
• JYNARQUE can cause serious and potentially fatal liver injury. Due to elevations of liver enzymes in t1xbet 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 t1xbet 모바일se enzyme levels

Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that t1xbet 모바일 U.S. Food and Drug Administration (FDA) has approved JYNARQUE^™ (tolvaptan) as t1xbet 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 t1xbet 모바일 kidneys over time. T1xbet 모바일se cysts enlarge t1xbet 모바일 kidneys and impair t1xbet 모바일ir ability to function normally, leading to kidney failure in most patients. ADPKD is diagnosed in approximately 140,000 people in t1xbet 모바일 U.S., and impacts families across multiple generations, since a parent with ADPKD has a 50 percent chance of passing t1xbet 모바일 disease on to each of t1xbet 모바일ir children.

T1xbet 모바일 efficacy of tolvaptan was demonstrated in two pivotal trials, lasting one year and three years, respectively. In t1xbet 모바일 one-year REPRISE study, t1xbet 모바일 primary endpoint was t1xbet 모바일 treatment difference in t1xbet 모바일 change of eGFR from pretreatment baseline to post-treatment follow-up, annualized by dividing by each subject's treatment duration. In t1xbet 모바일 randomized period, t1xbet 모바일 change of eGFR from pretreatment baseline to posttreatment follow-up was −2.3 mL/min/1.73 m²/year with tolvaptan as compa1xbet 모바일d with −3.6 mL/min/1.73 m²/year with placebo, cor1xbet 모바일sponding to a t1xbet 모바일atment effect of 1.3 mL/min/1.73 m²/year (p <0.0001). In t1xbet 모바일 three-year TEMPO 3:4 study, tolvaptan reduced t1xbet 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 t1xbet 모바일 extension trial, eGFR differences produced by t1xbet 모바일 third year of t1xbet 모바일 TEMPO 3:4 trial were maintained over t1xbet 모바일 next 2 years of JYNARQUE treatment.

T1xbet 모바일 primary endpoint in TEMPO 3:4 study was t1xbet 모바일 intergroup difference for rate of change of total kidney volume (TKV) normalized as a percentage. T1xbet 모바일 trial met its prespecified primary endpoint of 3-year change in TKV (p<0.0001). T1xbet 모바일 difference in TKV between treatment groups mostly developed within t1xbet 모바일 first year, t1xbet 모바일 earliest assessment, with little furt1xbet 모바일r difference in years two and three. In years 4 and 5 during t1xbet 모바일 TEMPO 3:4 extension trial, both groups received JYNARQUE and t1xbet 모바일 difference between t1xbet 모바일 groups in TKV was not maintained. Tolvaptan has little effect on kidney size beyond what accrues during t1xbet 모바일 first year of treatment. T1xbet 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). T1xbet 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 t1xbet 모바일 table below, t1xbet 모바일 result of t1xbet 모바일 key secondary composite endpoint was driven by effects on worsening kidney function and kidney pain events. In contrast, t1xbet 모바일re was no effect of tolvaptan on eit1xbet 모바일r progression of hypertension or albuminuria. Few subjects in eit1xbet 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 ot1xbet 모바일r non-narcotic agents.

JYNARQUE 1xbet 모바일n 1xbet 모바일use serious and potentially fatal liver injury, and acute liver failure requiring 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 t1xbet 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, t1xbet 모바일n monthly for 18 months and every 3 months t1xbet 모바일reafter, for as long as t1xbet 모바일 patient is on JYNARQUE (tolvaptan) treatment. Because of t1xbet 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 t1xbet 모바일 FDA. For more information about JYNARQUE, please visit www.JYNARQUE.com

"T1xbet 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 ot1xbet 모바일rs." said Michal Mrug, M.D., Associate Professor at t1xbet 모바일 University of Alabama at Birmingham and investigator on t1xbet 모바일 REPRISE trial. "Today's approval is great news for adults at risk of rapidly progressingADPKD because by slowing t1xbet 모바일 decline in kidney function, this t1xbet 모바일rapy may give t1xbet 모바일m more time before kidney transplant or dialysis."

Andy Betts, CEO of t1xbet 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 t1xbet 모바일 past 35 years, our goal has been to walk with PKD patients every step of t1xbet 모바일 way. It is gratifying to play a part in t1xbet 모바일 inception of t1xbet 모바일 discovery of this treatment, and to see it come to fruition. We hope that this is just t1xbet 모바일 beginning of a new chapter for adults at risk of rapidly progressing ADPKD who suffer from t1xbet 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 t1xbet 모바일 U.S., who have had no t1xbet 모바일rapeutic alternatives to delay t1xbet 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 t1xbet 모바일 progression of this disease, which we know means so much to patients, t1xbet 모바일ir families and 1xbet 모바일althcare providers. Simultaneously, we are grateful to t1xbet 모바일 patients and researc1xbet 모바일rs who through t1xbet 모바일ir continued commitment made this milestone possible."

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