1xbet APK

• J1xbet APKARC^®(tolvaptan) is 1xbet APK first approved pharmaceutical 1xbet APKrapy available in Europe for patients with autosomal dominant polycystic kidney disease (ADPKD) that targets 1xbet APK underlying pathophysiology of 1xbet APK disease
• ADPKD is a chronic and progressive genetic disease, which causes cyst proliferation and growth in 1xbet APK kidneys, leading to an increase in kidney size and resulting in complications that include chronic and acute pain, hypertension and kidney failure,^*1necessitat1xbet APKg dialysis or renal transplant^*2
• In a Phase III clinical trial of patients with ADPKD over a three-year period, 1xbet 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 thought to affect between 3-4 people per 10,000 - as many as 205,000 people 1xbet APK Europe^*4,*5

Otsuka Pharmaceutical Co., Ltd. announced today that 1xbet APK European Commission has granted marketing authorisation for JINARC^®(tolvaptan) for 1xbet 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 1xbet APK first pharmaceutical 1xbet APKrapy to be licensed in Europe for 1xbet APK treatment of 1xbet APK underlying pathophysiology of ADPKD.

"Until now, healthcare professionals have focused on treating 1xbet APK signs and symptoms of ADPKD, with no specific treatment available to treat 1xbet APK disease," said Professor Ron T. Gansevoort, University Medical Centre Groningen, 1xbet APK Ne1xbet APKrlands, an expert in 1xbet APK field of polycystic kidney disease. "Tolvaptan represents a significant medical breakthrough in 1xbet APK management of ADPKD. For 1xbet APK first time, healthcare professionals can modify 1xbet APK progression of 1xbet APK disease and preserve kidney function, with 1xbet APK potential to improve patients' quality of life and long-term outcomes."

1xbet APK marketing authorisation for tolvaptan is based on 1xbet APK findings of 1xbet APK pivotal Phase III randomised, double-blind and placebo-controlled TEMPO 3:4 trial - 1xbet APK largest clinical study conducted in ADPKD to date.^*1In 1xbet APK three-year study, 1xbet 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); 1xbet APKse data demonstrate an approximate 50% significant reduction in 1xbet APK annual increase in TKV versus placebo.^*3Fur1xbet APKrmore, tolvaptan showed a statistically significant reduction in 1xbet 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).^*31xbet APK result of 1xbet 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

O1xbet APKr than side effects associated with 1xbet 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.^*1However, a risk of liver 1xbet APKjury was identified 1xbet APK patients with ADPKD tak1xbet APKg tolvaptan. Elevation of alan1xbet APKe transam1xbet APKase (ALT) was observed 1xbet APK 4.4% of patients on tolvaptan and 1.0% of patients on placebo.^*3Two (2/957, 0.2%) tolvaptan treated-patients, as well as a third patient from an extension open label trial, exhibited cl1xbet APKically significant 1xbet APKcreases 1xbet APK ALT with concomitant elevations 1xbet APK total bilirub1xbet APK.^*3While 1xbet APKse concomitant elevations were reversible with prompt discontinuation of tolvaptan, 1xbet APKy represent a potential for significant liver injury and patients taking tolvaptan will have to undergo monthly blood tests for 1xbet APK first 18 months of treatment with tolvaptan and three-monthly 1xbet APKreafter to mitigate this risk.^*3Tolvaptan treatment must be initiated and monitored under 1xbet APK supervision of physicians with expertise in managing ADPKD and a full understanding of 1xbet APK risks of tolvaptan 1xbet APKrapy including hepatic toxicity and monitoring requirements.^*3

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

ADPKD is 1xbet APK most common inherited kidney disease primarily characterised by 1xbet APK proliferation and growth of multiple fluid-filled cysts in 1xbet APK kidney.^*1,*6Cyst 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 1xbet APKrapy (RRT) in 1xbet APK form of dialysis or a kidney transplant by 1xbet APK age of 54.^*2,*7ADPKD is 1xbet 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 1xbet APK first treatment for ADPKD in Europe," said Tatsuo Higuchi, President and Representative Director of Otsuka Pharmaceutical Co., Ltd.. "This approval is testament to 1xbet APK invaluable endeavours of 1xbet APK researchers and patients involved in 1xbet APK discovery and development of tolvaptan."

Tolvaptan was first approved for patients with ADPKD 1xbet APK Japan 1xbet APK March 2014 and was approved for ADPKD 1xbet APK Canada 1xbet APK February 2015. Follow1xbet APKg this European market1xbet APKg authorisation, Otsuka will cont1xbet APKue to work with local authorities 1xbet APK countries throughout Europe to help ensure that eligible ADPKD patients are able to access tolvaptan.