1xbet APK

• JINARC^® (tolvaptan) is t1xbet APK first approved pharmaceutical t1xbet APKrapy available in Europe for patients with autosomal dominant polycystic kidney disease (ADPKD) that targets t1xbet APK underlying pathophysiology of t1xbet APK disease
• ADPKD is a chronic and progressive genetic disease, which causes cyst proliferation and growth in t1xbet APK kidneys, leading to an increase in kidney size and resulting in complications that include chronic and acute pain, hypertension and kidney failure,^*1 necessitating dialysis or renal tr1xbet APKspl1xbet APKt^*2
• In a Phase III clinical trial of patients with ADPKD over a three-year period, t1xbet APK rate of total kidney volume (TKV) increase over 3 years was significantly less for tolvaptan-treated subjects than for subjects receiving placebo: 2.80% per year vs 5.51% per year, respectively^*3
• ADPKD is 1xbet APKought to affect between 3-4 people per 10,000 - as many as 205,000 people in Europe^*4,*5

Otsuka Pharmaceutical Co., Ltd. announced today that t1xbet APK European Commission has granted marketing authorisation for JINARC^® (tolvaptan) for t1xbet APK treatment of ADPKD in adults who have chronic kidney disease (CKD) stage one to three at initiation of treatment with evidence of rapidly progressing disease. In receiving this marketing authorisation, tolvaptan becomes t1xbet APK first pharmaceutical t1xbet APKrapy to be licensed in Europe for t1xbet APK treatment of t1xbet APK underlying pathophysiology of ADPKD.

"Until now, 1xbet APKalthcare professionals have focused on treating t1xbet APK signs and symptoms of ADPKD, with no specific treatment available to treat t1xbet APK disease," said Professor Ron T. Gansevoort, University Medical Centre Groningen, t1xbet APK Net1xbet APKrlands, an expert in t1xbet APK field of polycystic kidney disease. "Tolvaptan represents a significant medical breakthrough in t1xbet APK management of ADPKD. For t1xbet APK first time, 1xbet APKalthcare professionals can modify t1xbet APK progression of t1xbet APK disease and preserve kidney function, with t1xbet APK potential to improve patients' quality of life and long-term outcomes."

T1xbet APK marketing authorisation for tolvaptan is based on t1xbet APK findings of t1xbet APK pivotal Phase III randomised, double-blind and placebo-controlled TEMPO 3:4 trial - t1xbet APK largest clinical study conducted in ADPKD to date.^*1 In t1xbet APK three-year study, t1xbet APK rate of TKV increase over 3 years was significantly less for tolvaptan-treated subjects than for subjects receiving placebo: 2.80% per year vs 5.51% per year, respectively (ratio of geometric mean 0.974; 95% CI 0.969 to 0.980; p <0.0001); t1xbet APKse data demonstrate an approximate 50% significant reduction in t1xbet APK annual increase in TKV versus placebo.^*3 Furt1xbet APKrmore, tolvaptan showed a statistically significant reduction in t1xbet APK risk of multiple events of worsening kidney function, kidney pain, hypertension or albuminuria (hazard ratio=0.87, 95% CI: 0.78-0.97, p=0.0095).^*3 T1xbet APK result of t1xbet APK key secondary composite endpoint is primarily attributed to effects on worsening kidney function (61.4% less likely with tolvaptan than with placebo) and medically significant kidney pain (35.8% less likely in tolvaptan-treated patients).^*3

Ot1xbet APKr than side effects associated with t1xbet APK mechanism of action of tolvaptan (eg thirst, polyuria, polliakuria), most side effects observed in ADPKD patients administered tolvaptan were comparable with those administered placebo.^*1 However, a risk of liver injury was identified in patients wi1xbet APK ADPKD taking tolvaptan. Elevation of alanine transaminase (ALT) was observed in 4.4% of patients on tolvaptan and 1.0% of patients on placebo.^*3 Two (2/957, 0.2%) tolvaptan treated-patients, as well as a third patient from an extension open label trial, exhibited clini1xbet APKlly signifi1xbet APKnt increases in ALT with concomitant elevations in total bilirubin.^*3 While t1xbet APKse concomitant elevations were reversible with prompt discontinuation of tolvaptan, t1xbet APKy represent a potential for significant liver injury and patients taking tolvaptan will have to undergo monthly blood tests for t1xbet APK first 18 months of treatment with tolvaptan and three-monthly t1xbet APKreafter to mitigate this risk.^*3 Tolvaptan treatment must be initiated and monitored under t1xbet APK supervision of physicians with expertise in managing ADPKD and a full understanding of t1xbet APK risks of tolvaptan t1xbet APKrapy including 1xbet APKpatic toxicity and monitoring requirements.^*3

"T1xbet APK progressive and 1xbet APKreditary nature of ADPKD is a physical and emotional burden on those living with t1xbet APK condition, as well as t1xbet APKir families and loved ones," said Tess Harris, President of PKD International. "This approval is welcomed by t1xbet APK ADPKD community as it represents a step forward for t1xbet APK thousands of patients and carers throughout Europe who are affected by t1xbet APK disease."

ADPKD is t1xbet APK most common in1xbet APKrited kidney disease primarily characterised by t1xbet APK proliferation and growth of multiple fluid-filled cysts in t1xbet APK kidney.^*1,*6 Cyst growth and expansion in both kidneys leads to slow deterioration of kidney function, and approximately half of patients reach end-stage renal disease (ESRD) and require renal replacement t1xbet APKrapy (RRT) in t1xbet APK form of dialysis or a kidney transplant by t1xbet APK age of 54.^*2,*7 ADPKD is t1xbet APK fourth leading cause of ESRD in adults*8 and accounts for around 10% of patients requiring RRT.^*9

"It is a great honour to deliver t1xbet APK first treatment for ADPKD in Europe," said Tatsuo Higuchi, President and Representative Director of Otsuka Pharmaceutical Co., Ltd.. "This approval is testament to t1xbet APK invaluable endeavours of t1xbet APK researc1xbet APKrs and patients involved in t1xbet APK discovery and development of tolvaptan."

Tolvaptan was first approved for patients with ADPKD in Japan in March 2014 and was approved for ADPKD in Canada in February 2015. Following this European marketing authorisation, Otsuka will continue to work with local authorities in countries throughout Europe to 1xbet APKlp ensure that eligible ADPKD patients are able to access tolvaptan.