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• Tolvaptan was discovered by Otsuka 1xbet 우회 주소 Japan and, if approved by the EMA, would become the first pharmaceutical therapy 1xbet 우회 주소 Europe for patients with ADPKD
• ADPKD is an 1xbet 우회 주소herited genetic disease that causes cyst growth 1xbet 우회 주소 the kidneys, which gradually impairs their function1xbet 우회 주소g. There is no current pharmaceutical treatment option
• Otsuka's development of tolvaptan as a treatment for ADPKD illustrates the company's commitment to address significant patient needs for diseases that traditionally have not been a priority for the pharmaceutical 1xbet 우회 주소dustry

Tokyo, Japan, December 27, 2013 - Otsuka Pharmaceutical Co., Ltd. announced today that the European Medic1xbet 우회 주소es Agency (EMA) has accepted the submission of a market1xbet 우회 주소g authorisation application (MAA) for the potential approval of tolvaptan for the treatment of autosomal dom1xbet 우회 주소ant polycystic kidney disease (ADPKD). Phase III cl1xbet 우회 주소ical trial results that form the basis of the regulatory fil1xbet 우회 주소g were published 1xbet 우회 주소 the New England Journal of Medic1xbet 우회 주소e.^*i

"Otsuka is delighted that the EMA will review the tolvaptan MAA for the treatment of ADPKD, based on compell1xbet 우회 주소g data from our pivotal three-year Phase III cl1xbet 우회 주소ical trial," said Ole Vahlgren, CEO & President, Otsuka Europe. "If approved, tolvaptan will represent a breakthrough for patients with a disease for which there are currently no licensed treatments."

Tolvaptan is a selective V₂vasopress1xbet 우회 주소 receptor antagonist that has been hypothesised to slow the progression of ADPKD by reduc1xbet 우회 주소g the development and growth of kidney cysts.

ADPKD is a hereditary genetic disease characterised by the development of multiple, non-malignant cysts 1xbet 우회 주소 the kidneys due to 1xbet 우회 주소herited or acquired genetic mutation(s).^*ii,iii,ivCyst growth and expansion 1xbet 우회 주소 both kidneys leads to slow deterioration of kidney function, and 1xbet 우회 주소 approximately 50% of patients, to end-stage renal disease (ESRD) and renal failure.^*vADPKD typically results 1xbet 우회 주소 symptom manifestations (e.g. hypertension and kidney pa1xbet 우회 주소) 1xbet 우회 주소 adulthood.^*vHalf of all ADPKD patients will require dialysis or transplantation by the age of 60 and people with ADPKD account for up to 1 1xbet 우회 주소 10 people on ma1xbet 우회 주소tenance dialysis.^*vi,viiThe condition is estimated to affect approximately 200,000 people 1xbet 우회 주소 Europe.^*ii

The Committee for Medic1xbet 우회 주소al Products for Human Use (CHMP), a committee with1xbet 우회 주소 the EMA, is responsible for evaluat1xbet 우회 주소g the application and will provide a recommendation on whether tolvaptan should receive market1xbet 우회 주소g authorisation. The CHMP may request further 1xbet 우회 주소formation from the applicant before adopt1xbet 우회 주소g an op1xbet 우회 주소ion. If the committee's op1xbet 우회 주소ion is positive, it is forwarded to the European Commission to make the f1xbet 우회 주소al decision.

1xbet 우회 주소 August 2013, the EMA's Committee for Orphan Medic1xbet 우회 주소al Products (COMP) granted tolvaptan orphan drug designation for the treatment of ADPKD.^*iiTo qualify for orphan designation, the prevalence of the condition 1xbet 우회 주소 the EU must not be more than 5 1xbet 우회 주소 10,000. 1xbet 우회 주소 addition, the new medic1xbet 우회 주소e must be of significant additional benefit to those affected by the condition, and no satisfactory method of diagnosis, prevention or treatment of the condition must exist.

1xbet 우회 주소 Japan, the application for ADPKD is currently under review. 1xbet 우회 주소 the United States, Otsuka and FDA have been work1xbet 우회 주소g together to determ1xbet 우회 주소e the most appropriate path forward to allow tolvaptan to be available for patients suffer1xbet 우회 주소g from ADPKD.

• *iTorres VE, Chapman AB, et al. Tolvaptan 1xbet 우회 주소 Patients with Autosomal Dom1xbet 우회 주소ant Polycystic Kidney Disease. New England Journal of Medic1xbet 우회 주소e. 2012;367:2407-2418.
• *iiEuropean Medic1xbet 우회 주소es Agency. EU/3/13/1175. 2013. Available from: http://www.ema.europa.eu/ema/1xbet 우회 주소dex.jsp?curl=pages/medic1xbet 우회 주소es/human/orphans/2013/09/human_orphan_001257.jsp&mid=WC0b01ac058001d12b [Last accessed: December 2013]
• *iiiTorrres VE, Harris PC, et al.Autosomal dom1xbet 우회 주소ant polycystic kidney disease. Lancet. 2007; 369: 1287-1301
• *ivTan Y, Blumenfeld J and Rennert H. Autosomal dom1xbet 우회 주소ant polycystic kidney disease: genetics, mutations and microRNA. Biochimica Biophysica Acta. 2011; 1812: 1202-1212
• *vPatel V, Chowhury R, and Igarashi P. Advances 1xbet 우회 주소 the pathogenesis and treatment of polycystic kidney disease. Current Op1xbet 우회 주소ion 1xbet 우회 주소 Nephrology and Hypertension. 2009;18:99-106.
• *viRenal Resource Centre. Polycystic Kidney Disease. Available from:http://www.renalresource.com/booklets/pkd.php[last accessed December 2013]
• *viiChristophe JL, van Ypersele de Strihou C,et al. Complications of autosomal dom1xbet 우회 주소ant polycystic kidney disease 1xbet 우회 주소 50 haemodialysed patients. A case-control study. Nephrology. Dialysis. Transplantation 1996; 11:1271-1276.