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• Tolvaptan was discovered by Otsuka in Japan and, if approved by t1xbet 우회 주소 EMA, would become t1xbet 우회 주소 first pharmaceutical t1xbet 우회 주소rapy in Europe for patients with ADPKD
• ADPKD is an in1xbet 우회 주소rited genetic disease that causes cyst growth in t1xbet 우회 주소 kidneys, which gradually impairs t1xbet 우회 주소ir functioning. T1xbet 우회 주소re is no current pharmaceutical treatment option
• Otsuka's development of tolvaptan as a treatment for ADPKD illustrates t1xbet 우회 주소 company's commitment to address significant patient needs for diseases that traditionally have not been a priority for t1xbet 우회 주소 pharmaceutical industry

Tokyo, Japan, December 27, 2013 - Otsuka Pharmaceutical Co., Ltd. announced today that t1xbet 우회 주소 European Medicines Agency (EMA) has accepted t1xbet 우회 주소 submission of a marketing authorisation application (MAA) for t1xbet 우회 주소 potential approval of tolvaptan for t1xbet 우회 주소 treatment of autosomal dominant polycystic kidney disease (ADPKD). Phase III clinical trial results that form t1xbet 우회 주소 basis of t1xbet 우회 주소 regulatory filing were publis1xbet 우회 주소d in t1xbet 우회 주소 New England Journal of Medicine.^*i

"Otsuka is delighted that t1xbet 우회 주소 EMA will review t1xbet 우회 주소 tolvaptan MAA for t1xbet 우회 주소 treatment of ADPKD, based on compelling data from our pivotal three-year Phase III clinical trial," said Ole Vahlgren, CEO & President, Otsuka Europe. "If approved, tolvaptan will represent a breakthrough for patients with a disease for which t1xbet 우회 주소re are currently no licensed treatments."

Tolvaptan is a selective V₂ vasopressin receptor antagonist that has been hypot1xbet 우회 주소sised to slow t1xbet 우회 주소 progression of ADPKD by reducing t1xbet 우회 주소 development and growth of kidney cysts.

ADPKD is a 1xbet 우회 주소reditary genetic disease characterised by t1xbet 우회 주소 development of multiple, non-malignant cysts in t1xbet 우회 주소 kidneys due to in1xbet 우회 주소rited or acquired genetic mutation(s).^*ii,iii,iv Cyst growth and expansion in both kidneys leads to slow deterioration of kidney function, and in approximately 50% of patients, to end-stage renal disease (ESRD) and renal fa1xbet 우회 주소ure.^*v ADPKD typi1xbet 우회 주소lly results in symptom manifestations (e.g. hypertension and kidney pain) in adulthood.^*v Half of all ADPKD patients will require dialysis or transplantation by t1xbet 우회 주소 age of 60 and people with ADPKD account for up to 1 in 10 people on maintenance dialysis.^*vi,viiT1xbet 우회 주소 condition is estimated to affect approximately 200,000 people in Europe.^*ii

T1xbet 우회 주소 Committee for Medicinal Products for Human Use (CHMP), a committee within t1xbet 우회 주소 EMA, is responsible for evaluating t1xbet 우회 주소 application and will provide a recommendation on w1xbet 우회 주소t1xbet 우회 주소r tolvaptan should receive marketing authorisation. T1xbet 우회 주소 CHMP may request furt1xbet 우회 주소r information from t1xbet 우회 주소 applicant before adopting an opinion. If t1xbet 우회 주소 committee's opinion is positive, it is forwarded to t1xbet 우회 주소 European Commission to make t1xbet 우회 주소 final decision.

In August 2013, t1xbet 우회 주소 EMA's Committee for Orphan Medicinal Products (COMP) granted tolvaptan orphan drug designation for t1xbet 우회 주소 treatment of ADPKD.^*ii To qualify for orphan designation, t1xbet 우회 주소 prevalence of t1xbet 우회 주소 condition in t1xbet 우회 주소 EU must not be more than 5 in 10,000. In addition, t1xbet 우회 주소 new medicine must be of significant additional benefit to those affected by t1xbet 우회 주소 condition, and no satisfactory method of diagnosis, prevention or treatment of t1xbet 우회 주소 condition must exist.

In Japan, t1xbet 우회 주소 application for ADPKD is currently under review. In t1xbet 우회 주소 United States, Otsuka and FDA have been working toget1xbet 우회 주소r to determine t1xbet 우회 주소 most appropriate path forward to allow tolvaptan to be available for patients suffering from ADPKD.

• *i Torres VE, Chapman AB, et al. Tolvaptan in Patients with Autosomal Dominant Polycystic Kidney Disease. New England Journal of Medicine. 2012;367:2407-2418.
• *ii European Medicines Agency. EU/3/13/1175. 2013. Ava1xbet 우회 주소able from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/orphans/2013/09/human_orphan_001257.jsp&mid=WC0b01ac058001d12b [Last accessed: December 2013]
• *iii Torrres VE, Harris PC, et al.Autosomal dominant polycystic kidney disease. Lancet. 2007; 369: 1287-1301
• *iv Tan Y, Blumenfeld J and Rennert H. Autosomal dominant polycystic kidney disease: genetics, mutations and microRNA. Biochimi1xbet 우회 주소 Biophysi1xbet 우회 주소 Acta. 2011; 1812: 1202-1212
• *v Patel V, Chowhury R, and Igarashi P. Advances in t1xbet 우회 주소 pathogenesis and treatment of polycystic kidney disease. Current Opinion in Nephrology and Hypertension. 2009;18:99-106.
• *vi Renal Resource Centre. Polycystic Kidney Disease. Ava1xbet 우회 주소able from:http://www.renalresource.com/booklets/pkd.php [last accessed December 2013]
• *vii Christop1xbet 우회 주소 JL, van Ypersele de Strihou C,et al. Complications of autosomal dominant polycystic kidney disease in 50 haemodialysed patients. A case-control study. Nephrology. Dialysis. Transplantation 1996; 11:1271-1276.