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Tokyo, Japan - August 6, 2013 - Otsuka Pharmaceutical Co., Ltd. announced today the U.S. Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee voted against approval 1xbet 신청 tolvaptan for the treatment 1xbet 신청 ADPKD. The Advisory Committee voted 9 to 6 not to approve tolvaptan for ADPKD. The FDA is not bound by the Committee's guidance but takes its advice into consideration.

"While we are disappointed in the Committee's recommendation, we remain committed to providing patients and physicians with a novel treatment for ADPKD, a rare genetic disease. We are looking forward to continuing discussions with the FDA to address the panel's concerns," said Robert McQuade, Ph.D., Executive Vice President and Chief Strategic 1xbet 신청ficer, Otsuka Pharmaceutical Development & Commercialization Inc.

ADPKD is characterized predominantly by the formation 1xbet 신청 cysts in both kidneys that cause progressive kidney enlargement, and it is associated with pain, hypertension, decreased kidney function and ultimately, kidney failure.^*1The average age at which ADPKD patients enter end-stage renal d1xbet 신청ease (ESRD) 1xbet 신청 56.^*2Today, there are no treatment options specifically indicated for ADPKD and physicians have had limited resources to manage the disease, relying on symptom management, dialysis and transplantation as treatments 1xbet 신청 last resort when ADPKD progresses.^*1,3

The FDA accepted Otsuka's new drug application (NDA) for tolvaptan earlier this year, granting the drug a priority review status and assigning a Prescription Drug User Fee Act (PDUFA) goal date 1xbet 신청 September 1, 2013.

About Tolvaptan

Tolvaptan is currently under review as a treatment to slow the progression 1xbet 신청 kidney disease for patients at risk 1xbet 신청 rapidly progressing ADPKD. Tolvaptan was studied in patients with enlarged kidneys who were in chronic kidney disease (CKD) stages 1-3 at initiation 1xbet 신청 treatment. Results were published in the New England Journal 1xbet 신청 Medicine in December 2012.

Tolvaptan is believed to inhibit cyst formation, proliferation 1xbet 신청 growth.^*4Cyst formation is dependent on the binding 1xbet 신청 a hormone called arginine vasopressin to the V2 receptor.^*4,5Vasopressin acts as an agonist 1xbet 신청 the V2 receptor, accelerating cyst proliferation, fluid secretion into the cystic structures and cyst growth, ultimately leading to enlarged, dysfunctional kidneys.^*4,5Tolvaptan is a selective V2 receptor antagonist that blocks the vasopressin-mediated activation 1xbet 신청 the cyclic AMP pathway that leads to cell proliferation and fluid secretion.^*4

About ADPKD

ADPKD is the most common type 1xbet 신청 inherited genetic kidney disorders called polycystic kidney disease (PKD).^*6PKD is a progressive disease characterized predominantly by the development 1xbet 신청 numerous cysts in both kidneys.^*1The disease is caused by mutations 1xbet 신청 genes that regulate kidney function.^*6Two types 1xbet 신청 genetic mutations can cause ADPKD, the PKD1 mutation and the PKD2 mutation.^*6People with the PKD1 mutation generally have kidney d1xbet 신청ease that progresses more rapidly than people with the PKD2 mutation.^*6The genetic mutation that causes ADPKD is a dominant trait, which means that if a person has the disorder, there is a 50 percent chance that each 1xbet 신청 their children or siblings will also be at risk 1xbet 신청 developing the disease.^*1

ADPKD is a life-threatening disease that causes significant kidney damage 1xbet 신청 dysfunction.^*1,7It is the fourth leading cause 1xbet 신청 ESRD.^*7The average age at which ADPKD patients enter ESRD 1xbet 신청 56.²Kidneys affected by PKD become significantly enlarged, due to the formation and growth 1xbet 신청 multiple cysts which proliferate through healthy kidney tissue.^*1

• *1Polycystic Kidney Disease. National Kidney 1xbet 신청 Urologic Diseases Information Clearinghouse. (Sept., 2010). Retrieved June 17, 2013, from:http://kidney.niddk.nih.gov/kud1xbet 신청eases/pubs/polycystic/
• *2Ahsan A & Perrone R. "End-stage renal disease 1xbet 신청 polycystic kidney disease." Polycystic Kidney Disease: from Bench to Bedside 2013; 164-174 doi:10.2217/9781780841748
• *3Wüthrich, P and Changlin M. "Aquaretic Treatment in Polycystic Kidney Disease." The New England Journal 1xbet 신청 Medicine; 2012, 367 (25): 2440-2441
• *4Torres, VE et al. "Tolvaptan in Patients with Autosomal Dominant Polycystic Kidney Disease." The New England Journal 1xbet 신청 Medicine, 2012: 367 (25): 2407-2418
• *5Patel V, et al. "Advances in the Pathogenesis and Treatment 1xbet 신청 Polycystic Kidney Disease" University 1xbet 신청 Texas, Department 1xbet 신청 Pediatrics 2009
• *6Ahrabi, A, et al. "PKD1 Haploinsufficiency Causes a Syndrome 1xbet 신청 Inappropriate Antidiuresis in Mice" Journal 1xbet 신청 the American Society 1xbet 신청 Nephrology 2007; 18: 1740-1753
• *7Elhassan E, et al. "Progress on Autosomal Dominant Polycystic Kidney Disease." The Arab Journal 1xbet 신청 Nephrology and Transplantation 2009; 2(2): 27-44