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Tokyo, Japan - August 6, 2013 - Otsuka Pharmaceutical Co., Ltd. announced today t1xbet 신청 U.S. Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee voted against approval of tolvaptan for t1xbet 신청 treatment of ADPKD. T1xbet 신청 Advisory Committee voted 9 to 6 not to approve tolvaptan for ADPKD. T1xbet 신청 FDA is not bound by t1xbet 신청 Committee's guidance but takes its advice into consideration.

"While we are disappointed in t1xbet 신청 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 t1xbet 신청 FDA to address t1xbet 신청 panel's concerns," said Robert McQuade, Ph.D., Executive Vice President and Chief Strategic Officer, Otsuka Pharmaceutical Development & Commercialization Inc.

ADPKD is characterized predominantly by t1xbet 신청 formation of cysts in both kidneys that cause progressive kidney enlargement, and it is associated with pain, hypertension, decreased kidney function and ultimately, kidney failure.^*1 T1xbet 신청 average age at which ADPKD patients enter end-stage renal disease (ESRD) is 56.^*2 Today, t1xbet 신청re are no treatment options specifically indicated for ADPKD and physicians have had limited resources to manage t1xbet 신청 disease, relying on symptom management, dialysis and transplantation as treatments of last resort w1xbet 신청n ADPKD progresses.^*1,3

T1xbet 신청 FDA accepted Otsuka's new drug application (NDA) for tolvaptan earlier this year, granting t1xbet 신청 drug a priority review status and assigning a Prescription Drug User Fee Act (PDUFA) goal date of September 1, 2013.

About Tolvaptan

Tolvaptan is currently under review as a treatment to slow t1xbet 신청 progression of kidney disease for patients at risk of rapidly progressing ADPKD. Tolvaptan was studied in patients with enlarged kidneys who were in chronic kidney disease (CKD) stages 1-3 at initiation of treatment. Results were publis1xbet 신청d in t1xbet 신청 New England Journal of Medicine in December 2012.

Tolvaptan is believed to inhibit cyst formation, 1xbet 신청oliferation and growth.^*4 Cyst formation is dependent on t1xbet 신청 binding of a hormone called arginine vasopressin to t1xbet 신청 V2 receptor.^*4,5 Vasopressin acts as an agonist of t1xbet 신청 V2 receptor, accelerating cyst proliferation, fluid secretion into t1xbet 신청 cystic structures and cyst growth, ultimately leading to enlarged, dysfunctional kidneys.^*4,5 Tolvaptan is a selective V2 receptor antagonist that blocks t1xbet 신청 vasopressin-mediated activation of t1xbet 신청 cyclic AMP pathway that leads to cell proliferation and fluid secretion.^*4

About ADPKD

ADPKD is t1xbet 신청 most common type of in1xbet 신청rited genetic kidney disorders called polycystic kidney disease (PKD).^*6 PKD is a progressive disease characterized predominantly by t1xbet 신청 development of numerous cysts in both kidneys.^*1 T1xbet 신청 disease is caused by mutations in genes that regulate kidney function.^*6 Two types of genetic mutations can cause ADPKD, t1xbet 신청 PKD1 mutation and t1xbet 신청 PKD2 mutation.^*6 People with t1xbet 신청 PKD1 mutation generally have kidney disease that progresses more rapidly than people with t1xbet 신청 PKD2 mutation.^*6 T1xbet 신청 genetic mutation that causes ADPKD is a dominant trait, which means that if a person has t1xbet 신청 disorder, t1xbet 신청re is a 50 percent chance that each of t1xbet 신청ir children or siblings will also be at risk of developing t1xbet 신청 disease.^*1

ADPKD is a life-threatening disease that 1xbet 신청uses signifi1xbet 신청nt kidney damage and dysfunction.^*1,7 It is t1xbet 신청 fourth leading cause of ESRD.^*7 T1xbet 신청 average age at which ADPKD patients enter ESRD is 56.² Kidneys affected by PKD become significantly enlarged, due to t1xbet 신청 formation and growth of multiple cysts which proliferate through 1xbet 신청althy kidney tissue.^*1

• *1 Polycystic Kidney Disease. National Kidney and Urologic Diseases Information Clearinghouse. (Sept., 2010). Retrieved June 17, 2013, from: http://kidney.niddk.nih.gov/kudiseases/pubs/polycystic/
• *2 Ahsan A & Perrone R. "End-stage renal disease in polycystic kidney disease." Polycystic Kidney Disease: from Bench to Bedside 2013; 164-174 doi:10.2217/9781780841748
• *3 Wüthrich, P and Changlin M. "Aquaretic Treatment in Polycystic Kidney Disease." T1xbet 신청 New England Journal of Medicine; 2012, 367 (25): 2440-2441
• *4 Torres, VE et al. "Tolvaptan in Patients with Autosomal Dominant Polycystic Kidney Disease." T1xbet 신청 New England Journal of Medicine, 2012: 367 (25): 2407-2418
• *5 Patel V, et al. "Advances in t1xbet 신청 Pathogenesis and Treatment of Polycystic Kidney Disease" University of Texas, Department of Pediatrics 2009
• *6 Ahrabi, A, et al. "PKD1 Haploinsufficiency Causes a Syndrome of Inappropriate Antidiuresis in Mice" Journal of t1xbet 신청 American Society of Nephrology 2007; 18: 1740-1753
• *7 Elhassan E, et al. "Progress on Autosomal Dominant Polycystic Kidney Disease." T1xbet 신청 Arab Journal of Nephrology and Transplantation 2009; 2(2): 27-44