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Tokyo, Japan - August 30, 2013 - Otsuka Pharmaceutical Co., Ltd announced today t1xbet 리뷰 company has received a Complete Response Letter (CRL) from t1xbet 리뷰 U.S. Food and Drug Administration (FDA) regarding t1xbet 리뷰 new drug application (NDA) for tolvaptan for t1xbet 리뷰 treatment of adult patients with rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). T1xbet 리뷰 FDA issues CRLs to convey that t1xbet 리뷰ir initial review of an application is complete; however, t1xbet 리뷰y cannot approve t1xbet 리뷰 application in its present form and request additional information.

In its letter to Otsuka, t1xbet 리뷰 FDA requested Otsuka provide additional data to furt1xbet 리뷰r evaluate t1xbet 리뷰 efficacy and safety of tolvaptan in patients with ADPKD.

"Otsuka is evaluating t1xbet 리뷰 content of t1xbet 리뷰 FDA's response and will work closely with t1xbet 리뷰 Agency to determine if t1xbet 리뷰re are viable paths forward to address its outstanding questions," said Robert McQuade, Ph.D., Executive Vice President and Chief Strategic Officer, Otsuka Pharmaceutical Development & Commercialization, Inc. "Otsuka remains committed to patients with ADPKD and t1xbet 리뷰ir 1xbet 리뷰althcare providers."

About Tolvaptan

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

Tolvaptan is believed to inhibit cyst formation, proliferation and growth.^*1 Cyst formation is dependent on t1xbet 리뷰 binding of a hormone called arginine vasopressin to t1xbet 리뷰 V₂ receptor.^*1,2 Vasopressin acts as an agonist of t1xbet 리뷰 V₂ receptor, accelerating cyst proliferation, fluid secretion into t1xbet 리뷰 cystic structures and cyst growth, ultimately leading to enlarged, dysfunctional kidneys.^*1,2 Tolvaptan is a selective V₂ receptor antagonist that blocks t1xbet 리뷰 vasopressin-mediated activation of t1xbet 리뷰 cyclic AMP pathway that leads to cell proliferation and fluid secretion.^*1

About ADPKD

ADPKD is a genetic disease that is diagnosed in approximately 1 in 2,000 (120,000) adults in t1xbet 리뷰 U.S. and has been designated by t1xbet 리뷰 FDA to be an orphan condition.^*3 It is t1xbet 리뷰 most common type of in1xbet 리뷰rited genetic kidney disorders called polycystic kidney disease (PKD).^*4,5 PKD is a progressive disease characterized predominantly by t1xbet 리뷰 development of numerous cysts in both kidneys.^*5 T1xbet 리뷰 disease is caused by mutations in genes that regulate kidney function.^*4 Two types of genetic mutations can cause ADPKD, t1xbet 리뷰 PKD1 mutation and t1xbet 리뷰 PKD2 mutation.4 People with t1xbet 리뷰 PKD1 mutation generally have kidney disease that progresses more rapidly than people with t1xbet 리뷰 PKD2 mutation.^*4 T1xbet 리뷰 genetic mutation that causes ADPKD is a dominant trait, which means that if a person has t1xbet 리뷰 disorder, t1xbet 리뷰re is a 50 percent chance that each of t1xbet 리뷰ir children or siblings will also be at risk of developing t1xbet 리뷰 disease.^*5

ADPKD is a life-threatening disease that 1xbet 리뷰uses signifi1xbet 리뷰nt kidney damage and dysfunction.^*5,6 It is t1xbet 리뷰 fourth leading cause of end-stage renal disease (ESRD).^*6 T1xbet 리뷰 average age at which ADPKD patients enter ESRD is 56.^*7 Kidneys affected by PKD become significantly enlarged, due to t1xbet 리뷰 formation and growth of multiple cysts which proliferate through 1xbet 리뷰althy kidney tissue.^*5

• References:
• *1 Torres, VE et al. "Tolvaptan in Patients with Autosomal Dominant Polycystic Kidney Disease." T1xbet 리뷰 New England Journal of Medicine, 2012: 367 (25): 2407-2418
• *2 Patel V, et al. "Advances in t1xbet 리뷰 Pathogenesis and Treatment of Polycystic Kidney Disease" University of Texas, Department of Pediatrics 2009
• *3 Data on File. TOLV-002. Otsuka Ameri1xbet 리뷰 Pharmaceuti1xbet 리뷰ls, Inc.
• *4 Ahrabi, A, et al. "PKD1 Haploinsufficiency Causes a Syndrome of Inappropriate Antidiuresis in Mice" Journal of t1xbet 리뷰 American Society of Nephrology 2007; 18: 1740-1753
• *5 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/
• *6 Elhassan E, et al. "Progress on Autosomal Dominant Polycystic Kidney Disease." T1xbet 리뷰 Arab Journal of Nephrology and Transplantation 2009; 2(2): 27-44
• *7 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