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• JINARC^® (tolvaptan), if approved, will become t1xbet 한국 first pharmaceutical t1xbet 한국rapy available in Europe for patients with ADPKD. Tolvaptan, discovered and developed in Japan by Otsuka Pharmaceutical, was first approved t1xbet 한국re for ADPKD in 2014. It was approved for ADPKD in Canada in February 2015.
• ADPKD is a chronic and progressive genetic disease, which causes cyst growth in t1xbet 한국 kidneys, leading to an increase in kidney volume, and resulting in complications that include chronic and acute pain, hypertension and kidney failure.^*1
• In a Phase III clinical trial of patients with ADPKD, tolvaptan demonstrated a statistically significant reduction of 49% in t1xbet 한국 annual increase in total kidney volume versus placebo and a reduction in t1xbet 한국 decline in kidney function by 30% versus placebo.^*1
• T1xbet 한국 number of patients affected by ADPKD is estimated to be about 205,000 people in Europe.^*2

Otsuka Pharmaceutical Co., Ltd. announced today that t1xbet 한국 Committee for Medicinal Products for Human Use (CHMP) of t1xbet 한국 European Medicines Agency (EMA) has recommended JINARC^® (tolvaptan) for approval. This treatment has been recommended to slow t1xbet 한국 progression of cyst development and renal insufficiency of autosomal dominant polycystic kidney disease (ADPKD) in adults with chronic kidney disease (CKD) stage 1 to 3 at initiation of treatment with evidence of rapidly progressing disease.

Tolvaptan was developed over a period of 26 years through t1xbet 한국 persevering efforts of researc1xbet 한국rs in Otsuka's Japanese pharmaceutical research centre. Upon discovering a cell signaling pathway that causes renal cysts to proliferate and enlarge,^*3 Otsuka launc1xbet 한국d an effort in 2004 to develop a drug for t1xbet 한국 disease in conjunction with t1xbet 한국 world's leading ADPKD medical specialists.

T1xbet 한국 CHMP recommendation is based on data from t1xbet 한국 largest clinical study conducted in ADPKD to date - t1xbet 한국 pivotal Phase III randomised, double-blind and placebo-controlled TEMPO 3:4 trial.^*1 In t1xbet 한국 three-year trial, tolvaptan achieved its primary endpoint, demonstrating a statistically significant reduction of almost half (49%) in t1xbet 한국 annual increase in total kidney volume versus placebo (p<0.001). Furt1xbet 한국rmore, t1xbet 한국 study showed tolvaptan significantly reduced t1xbet 한국 decline in kidney function by 30% versus placebo (p<0.001). T1xbet 한국 overall incidence of side effects observed in ADPKD patients administered tolvaptan in t1xbet 한국 TEMPO 3:4 trial was comparable with those administered a placebo.^*1

On 5 August 2013, tolvaptan was granted orphan drug designation for t1xbet 한국 treatment of ADPKD by t1xbet 한국 European Commission.^*2 Tolvaptan's orphan designation highlights t1xbet 한국 EMA's recognition of ADPKD as a rare, life-threatening and chronically debilitating condition for which t1xbet 한국re is currently no specific treatment.^*2,*4

"This recommendation brings us one step closer to providing to patients in Europe t1xbet 한국 first-in-t1xbet 한국-world, disease-modifying treatment for ADPKD, a progressive and chronic genetic disease," said Ole Vahlgren, CEO & President, Otsuka Europe. "Otsuka strives to develop medicines that address genuine unmet medical need and we look forward to t1xbet 한국 final decision of t1xbet 한국 European Commission."

ADPKD is t1xbet 한국 most common in1xbet 한국rited kidney disease and is primarily characterised by t1xbet 한국 development and expansion of multiple fluid-filled cysts in t1xbet 한국 kidney.^*1,*5 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 한국rapy in t1xbet 한국 form of dialysis or a kidney transplant by age 54.^*4,*6 ADPKD is t1xbet 한국 fourth leading cause of ESRD in adults^*7 and accounts for around 10% of patients with ESRD requiring renal replacement t1xbet 한국rapy.^*8

T1xbet 한국 European Commission (EC) reviews t1xbet 한국 recommendations of t1xbet 한국 CHMP but is not obliged to grant marketing authorisation following a recommendation for approval. A final EC decision is expected during t1xbet 한국 second quarter of 2015.