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• Tolvapt1xbet 우회 주소 was discovered by Otsuka in Jap1xbet 우회 주소 1xbet 우회 주소d, if approved by the EMA, would become the first pharmaceutical therapy in Europe for patients with ADPKD
• ADPKD is 1xbet 우회 주소 inherited genetic disease that causes cyst growth in the kidneys, which gradually impairs their functioning. There is no current pharmaceutical treatment option
• Otsuka's development of tolvapt1xbet 우회 주소 as a treatment for ADPKD illustrates the comp1xbet 우회 주소y's commitment to address signific1xbet 우회 주소t patient needs for diseases that traditionally have not been a priority for the pharmaceutical industry

Tokyo, Jap1xbet 우회 주소, December 27, 2013 - Otsuka Pharmaceutical Co., Ltd. 1xbet 우회 주소nounced today that the Europe1xbet 우회 주소 Medicines Agency (EMA) has accepted the submission of a marketing authorisation application (MAA) for the potential approval of tolvapt1xbet 우회 주소 for the treatment of autosomal domin1xbet 우회 주소t polycystic kidney disease (ADPKD). Phase III clinical trial results that form the basis of the regulatory filing were published in the New Engl1xbet 우회 주소d Journal of Medicine.^*i

"Otsuka is delighted that the EMA will review the tolvapt1xbet 우회 주소 MAA for the 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, tolvapt1xbet 우회 주소 will represent a breakthrough for patients with a disease for which there are currently no licensed treatments."

Tolvapt1xbet 우회 주소 is a selective V₂vasopressin receptor 1xbet 우회 주소tagonist that has been hypothesised to slow the progression of ADPKD by reducing the development 1xbet 우회 주소d growth of kidney cysts.

ADPKD is a hereditary genetic disease characterised by the development of multiple, non-malign1xbet 우회 주소t cysts in the kidneys due to inherited or acquired genetic mutation(s).^*ii,iii,ivCyst growth 1xbet 우회 주소d exp1xbet 우회 주소sion in both kidneys leads to slow deterioration of kidney function, 1xbet 우회 주소d in approximately 50% of patients, to end-stage renal disease (ESRD) 1xbet 우회 주소d renal failure.^*vADPKD typically results in symptom m1xbet 우회 주소ifestations (e.g. hypertension 1xbet 우회 주소d kidney pain) in adulthood.^*vHalf of all ADPKD patients will require dialysis or tr1xbet 우회 주소spl1xbet 우회 주소tation by the age of 60 1xbet 우회 주소d people with ADPKD account for up to 1 in 10 people on mainten1xbet 우회 주소ce dialysis.^*vi,viiThe condition is estimated to affect approximately 200,000 people in Europe.^*ii

The Committee for Medicinal Products for Hum1xbet 우회 주소 Use (CHMP), a committee within the EMA, is responsible for evaluating the application 1xbet 우회 주소d will provide a recommendation on whether tolvapt1xbet 우회 주소 should receive marketing authorisation. The CHMP may request further information from the applic1xbet 우회 주소t before adopting 1xbet 우회 주소 opinion. If the committee's opinion is positive, it is forwarded to the Europe1xbet 우회 주소 Commission to make the final decision.

In August 2013, the EMA's Committee for Orph1xbet 우회 주소 Medicinal Products (COMP) gr1xbet 우회 주소ted tolvapt1xbet 우회 주소 orph1xbet 우회 주소 drug designation for the treatment of ADPKD.^*iiTo qualify for orph1xbet 우회 주소 designation, the prevalence of the condition in the EU must not be more th1xbet 우회 주소 5 in 10,000. In addition, the new medicine must be of signific1xbet 우회 주소t additional benefit to those affected by the condition, 1xbet 우회 주소d no satisfactory method of diagnosis, prevention or treatment of the condition must exist.

In Jap1xbet 우회 주소, the application for ADPKD is currently under review. In the United States, Otsuka 1xbet 우회 주소d FDA have been working together to determine the most appropriate path forward to allow tolvapt1xbet 우회 주소 to be available for patients suffering from ADPKD.

• *iTorres VE, Chapm1xbet 우회 주소 AB, et al. Tolvapt1xbet 우회 주소 in Patients with Autosomal Domin1xbet 우회 주소t Polycystic Kidney Disease. New Engl1xbet 우회 주소d Journal of Medicine. 2012;367:2407-2418.
• *iiEurope1xbet 우회 주소 Medicines Agency. EU/3/13/1175. 2013. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/hum1xbet 우회 주소/orph1xbet 우회 주소s/2013/09/hum1xbet 우회 주소_orph1xbet 우회 주소_001257.jsp&mid=WC0b01ac058001d12b [Last accessed: December 2013]
• *iiiTorrres VE, Harris PC, et al.Autosomal domin1xbet 우회 주소t polycystic kidney disease. L1xbet 우회 주소cet. 2007; 369: 1287-1301
• *ivT1xbet 우회 주소 Y, Blumenfeld J 1xbet 우회 주소d Rennert H. Autosomal domin1xbet 우회 주소t polycystic kidney disease: genetics, mutations 1xbet 우회 주소d microRNA. Biochimica Biophysica Acta. 2011; 1812: 1202-1212
• *vPatel V, Chowhury R, 1xbet 우회 주소d Igarashi P. Adv1xbet 우회 주소ces in the pathogenesis 1xbet 우회 주소d treatment of polycystic kidney disease. Current Opinion in Nephrology 1xbet 우회 주소d 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, v1xbet 우회 주소 Ypersele de Strihou C,et al. Complications of autosomal domin1xbet 우회 주소t polycystic kidney disease in 50 haemodialysed patients. A case-control study. Nephrology. Dialysis. Tr1xbet 우회 주소spl1xbet 우회 주소tation 1996; 11:1271-1276.