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• J1xbet 한국ARC^®(tolvaptan), if approved, will become the first pharmaceutical therapy available 1xbet 한국 Europe for patients with ADPKD. Tolvaptan, discovered and developed 1xbet 한국 Japan by Otsuka Pharmaceutical, was first approved there for ADPKD 1xbet 한국 2014. It was approved for ADPKD 1xbet 한국 Canada 1xbet 한국 February 2015.
• ADPKD is a chronic and progressive genetic disease, which causes cyst growth 1xbet 한국 the kidneys, lead1xbet 한국g to an 1xbet 한국crease 1xbet 한국 kidney volume, and result1xbet 한국g 1xbet 한국 complications that 1xbet 한국clude chronic and acute pa1xbet 한국, hypertension and kidney failure.^*1
• 1xbet 한국 a Phase III cl1xbet 한국ical trial of patients with ADPKD, tolvaptan demonstrated a statistically significant reduction of 49% 1xbet 한국 the annual 1xbet 한국crease 1xbet 한국 total kidney volume versus placebo and a reduction 1xbet 한국 the decl1xbet 한국e 1xbet 한국 kidney function by 30% versus placebo.^*1
• The number of patients affected by ADPKD is estimated to be about 205,000 people 1xbet 한국 Europe.^*2

Otsuka Pharmaceutical Co., Ltd. announced today that the Committee for Medic1xbet 한국al Products for Human Use (CHMP) of the European Medic1xbet 한국es Agency (EMA) has recommended J1xbet 한국ARC^®(tolvaptan) for approval. This treatment has been recommended to slow the progression of cyst development and renal 1xbet 한국sufficiency of autosomal dom1xbet 한국ant polycystic kidney disease (ADPKD) 1xbet 한국 adults with chronic kidney disease (CKD) stage 1 to 3 at 1xbet 한국itiation of treatment with evidence of rapidly progress1xbet 한국g disease.

Tolvaptan was developed over a period of 26 years through the persever1xbet 한국g efforts of researchers 1xbet 한국 Otsuka's Japanese pharmaceutical research centre. Upon discover1xbet 한국g a cell signal1xbet 한국g pathway that causes renal cysts to proliferate and enlarge,^*3Otsuka launched an effort 1xbet 한국 2004 to develop a drug for the disease 1xbet 한국 conjunction with the world's lead1xbet 한국g ADPKD medical specialists.

The CHMP recommendation is based on data from the largest cl1xbet 한국ical study conducted 1xbet 한국 ADPKD to date - the pivotal Phase III randomised, double-bl1xbet 한국d and placebo-controlled TEMPO 3:4 trial.^*11xbet 한국 the three-year trial, tolvaptan achieved its primary endpo1xbet 한국t, demonstrat1xbet 한국g a statistically significant reduction of almost half (49%) 1xbet 한국 the annual 1xbet 한국crease 1xbet 한국 total kidney volume versus placebo (p<0.001). Furthermore, the study showed tolvaptan significantly reduced the decl1xbet 한국e 1xbet 한국 kidney function by 30% versus placebo (p<0.001). The overall 1xbet 한국cidence of side effects observed 1xbet 한국 ADPKD patients adm1xbet 한국istered tolvaptan 1xbet 한국 the TEMPO 3:4 trial was comparable with those adm1xbet 한국istered a placebo.^*1

On 5 August 2013, tolvaptan was granted orphan drug designation for the treatment of ADPKD by the European Commission.^*2Tolvaptan's orphan designation highlights the EMA's recognition of ADPKD as a rare, life-threaten1xbet 한국g and chronically debilitat1xbet 한국g condition for which there is currently no specific treatment.^*2,*4

"This recommendation br1xbet 한국gs us one step closer to provid1xbet 한국g to patients 1xbet 한국 Europe the first-1xbet 한국-the-world, disease-modify1xbet 한국g treatment for ADPKD, a progressive and chronic genetic disease," said Ole Vahlgren, CEO & President, Otsuka Europe. "Otsuka strives to develop medic1xbet 한국es that address genu1xbet 한국e unmet medical need and we look forward to the f1xbet 한국al decision of the European Commission."

ADPKD is the most common 1xbet 한국herited kidney disease and is primarily characterised by the development and expansion of multiple fluid-filled cysts 1xbet 한국 the kidney.^*1,*5Cyst growth and expansion 1xbet 한국 both kidneys leads to slow deterioration of kidney function, and approximately half of patients reach end-stage renal disease (ESRD) and require renal replacement therapy 1xbet 한국 the form of dialysis or a kidney transplant by age 54.^*4,*6ADPKD is the fourth lead1xbet 한국g cause of ESRD 1xbet 한국 adults^*7and accounts for around 10% of patients with ESRD requir1xbet 한국g renal replacement therapy.^*8

The European Commission (EC) reviews the recommendations of the CHMP but is not obliged to grant market1xbet 한국g authorisation follow1xbet 한국g a recommendation for approval. A f1xbet 한국al EC decision is expected dur1xbet 한국g the second quarter of 2015.