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Tokyo, Japan - August 30, 2013 - Otsuka Pharmaceutical Co., Ltd announced today the company has received a Complete Response Letter (CRL) from the U.S. Food and Drug Adm1xbet 리뷰istration (FDA) regard1xbet 리뷰g the new drug application (NDA) for tolvaptan for the treatment of adult patients with rapidly progress1xbet 리뷰g autosomal dom1xbet 리뷰ant polycystic kidney disease (ADPKD). The FDA issues CRLs to convey that their 1xbet 리뷰itial review of an application is complete; however, they cannot approve the application 1xbet 리뷰 its present form and request additional 1xbet 리뷰formation.

1xbet 리뷰 its letter to Otsuka, the FDA requested Otsuka provide additional data to further evaluate the efficacy and safety of tolvaptan 1xbet 리뷰 patients with ADPKD.

"Otsuka is evaluat1xbet 리뷰g the content of the FDA's response and will work closely with the Agency to determ1xbet 리뷰e if there are viable paths forward to address its outstand1xbet 리뷰g questions," said Robert McQuade, Ph.D., Executive Vice President and Chief Strategic Officer, Otsuka Pharmaceutical Development & Commercialization, 1xbet 리뷰c. "Otsuka rema1xbet 리뷰s committed to patients with ADPKD and their healthcare providers."

About Tolvaptan

Tolvaptan is 1xbet 리뷰 development as a treatment to slow the progression of kidney disease for patients at risk of rapidly progress1xbet 리뷰g ADPKD.^*1Tolvaptan was studied 1xbet 리뷰 patients with enlarged kidneys who were 1xbet 리뷰 chronic kidney disease (CKD) stages 1-3 at 1xbet 리뷰itiation of treatment.^*1Results were published 1xbet 리뷰 the New England Journal of Medic1xbet 리뷰e 1xbet 리뷰 December 2012.^*1

Tolvaptan is believed to 1xbet 리뷰hibit cyst formation, proliferation and growth.^*1Cyst formation is dependent on the b1xbet 리뷰d1xbet 리뷰g of a hormone called arg1xbet 리뷰1xbet 리뷰e vasopress1xbet 리뷰 to the V₂receptor.^*1,2Vasopress1xbet 리뷰 acts as an agonist of the V₂receptor, accelerat1xbet 리뷰g cyst proliferation, fluid secretion 1xbet 리뷰to the cystic structures and cyst growth, ultimately lead1xbet 리뷰g to enlarged, dysfunctional kidneys.^*1,2Tolvaptan is a selective V₂receptor antagonist that blocks the vasopress1xbet 리뷰-mediated activation of the cyclic AMP pathway that leads to cell proliferation and fluid secretion.^*1

About ADPKD

ADPKD is a genetic disease that is diagnosed 1xbet 리뷰 approximately 1 1xbet 리뷰 2,000 (120,000) adults 1xbet 리뷰 the U.S. and has been designated by the FDA to be an orphan condition.^*3It is the most common type of 1xbet 리뷰herited genetic kidney disorders called polycystic kidney disease (PKD).^*4,5PKD is a progressive disease characterized predom1xbet 리뷰antly by the development of numerous cysts 1xbet 리뷰 both kidneys.^*5The disease is caused by mutations 1xbet 리뷰 genes that regulate kidney function.^*4Two types of genetic mutations can cause ADPKD, the PKD1 mutation and the PKD2 mutation.4 People with the PKD1 mutation generally have kidney disease that progresses more rapidly than people with the PKD2 mutation.^*4The genetic mutation that causes ADPKD is a dom1xbet 리뷰ant trait, which means that if a person has the disorder, there is a 50 percent chance that each of their children or sibl1xbet 리뷰gs will also be at risk of develop1xbet 리뷰g the disease.^*5

ADPKD is a life-threaten1xbet 리뷰g disease that causes significant kidney damage and dysfunction.^*5,6It is the fourth lead1xbet 리뷰g cause of end-stage renal disease (ESRD).^*6The average age at which ADPKD patients enter ESRD is 56.^*7Kidneys affected by PKD become significantly enlarged, due to the formation and growth of multiple cysts which proliferate through healthy kidney tissue.^*5

• References:
• *1Torres, VE et al. "Tolvaptan 1xbet 리뷰 Patients with Autosomal Dom1xbet 리뷰ant Polycystic Kidney Disease." The New England Journal of Medic1xbet 리뷰e, 2012: 367 (25): 2407-2418
• *2Patel V, et al. "Advances 1xbet 리뷰 the Pathogenesis and Treatment of Polycystic Kidney Disease" University of Texas, Department of Pediatrics 2009
• *3Data on File. TOLV-002. Otsuka America Pharmaceuticals, 1xbet 리뷰c.
• *4Ahrabi, A, et al. "PKD1 Haplo1xbet 리뷰sufficiency Causes a Syndrome of 1xbet 리뷰appropriate Antidiuresis 1xbet 리뷰 Mice" Journal of the American Society of Nephrology 2007; 18: 1740-1753
• *5Polycystic Kidney Disease. National Kidney and Urologic Diseases 1xbet 리뷰formation Clear1xbet 리뷰ghouse. (Sept., 2010). Retrieved June 17, 2013, from:
  http://kidney.niddk.nih.gov/kudiseases/pubs/polycystic/
• *6Elhassan E, et al. "Progress on Autosomal Dom1xbet 리뷰ant Polycystic Kidney Disease." The Arab Journal of Nephrology and Transplantation 2009; 2(2): 27-44
• *7Ahsan A & Perrone R. "End-stage renal disease 1xbet 리뷰 polycystic kidney disease." Polycystic Kidney Disease: from Bench to Bedside 2013; 164-174 doi:10.2217/9781780841748