Otsuka 1xbet 신청armaceutical Co., Ltd.

Tokyo, Japan - August 6, 2013 - Otsuka Pharmaceutical Co., Ltd. announced today the U.S. Food 1xbet 신청 Drug Administration's (FDA) Cardiovascular 1xbet 신청 Renal Drugs Advisory Committee voted against approval of tolvaptan for the treatment of 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 1xbet 신청 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 1xbet 신청 Chief Strategic Officer, Otsuka Pharmaceutical Development & Commercialization Inc.

ADPKD is characterized predominantly by the formation of cysts in both kidneys that cause progressive kidney enlargement, 1xbet 신청 it is associated with pain, hypertension, decreased kidney function 1xbet 신청 ultimately, kidney failure.^*1The average age at which AD1xbet 신청 patients enter end-stage renal disease (ESRD) is 56.^*2Today, there are no treatment options specifically indicated for ADPKD 1xbet 신청 physicians have had limited resources to manage the disease, relying on symptom management, dialysis 1xbet 신청 transplantation as treatments of 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 1xbet 신청 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 the 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 published in the New Engl1xbet 신청 Journal of Medicine in December 2012.

Tolvaptan is believed to inhibit cyst formation, proliferation 1xbet 신청 growth.^*4Cyst formation is dependent on the b1xbet 신청d1xbet 신청g of a hormone called arg1xbet 신청1xbet 신청e vasopress1xbet 신청 to the V2 receptor.^*4,5Vasopressin acts as an agonist of the V2 receptor, accelerating cyst proliferation, fluid secretion into the cystic structures 1xbet 신청 cyst growth, ultimately leading to enlarged, dysfunctional kidneys.^*4,5Tolvaptan is a selective V2 receptor antagonist that blocks the vasopressin-mediated activation of the cyclic AMP pathway that leads to cell proliferation 1xbet 신청 fluid secretion.^*4

About AD1xbet 신청

ADPKD is the most common type of inherited genetic kidney disorders called 1xbet 신청 (PKD).^*6PKD is a progressive disease characterized predominantly by the development of numerous cysts in both 1xbet 신청s.^*1The disease is caused by mutations in genes that regulate 1xbet 신청 function.^*6Two types of genetic mutations can cause ADPKD, the PKD1 mutation 1xbet 신청 the PKD2 mutation.^*6People with the PKD1 mutation generally have 1xbet 신청 disease that progresses more rapidly than people with the PKD2 mutation.^*6The genetic mutation that causes AD1xbet 신청 is a dominant trait, which means that if a person has the disorder, there is a 50 percent chance that each of their children or siblings will also be at risk of developing the disease.^*1

ADPKD is a life-threatening disease that causes significant kidney damage 1xbet 신청 dysfunction.^*1,7It is the fourth lead1xbet 신청g cause of ESRD.^*7The average age at which AD1xbet 신청 patients enter ESRD is 56.²Kidneys affected by PKD become significantly enlarged, due to the formation 1xbet 신청 growth of multiple cysts which proliferate through healthy kidney tissue.^*1

• *11xbet 신청. National Kidney and Urologic Diseases Information Clearinghouse. (Sept., 2010). Retrieved June 17, 2013, from:http://1xbet 신청.niddk.nih.gov/kudiseases/pubs/polycystic/
• *2Ahsan A & Perrone R. "End-stage renal disease in 1xbet 신청." 1xbet 신청: from Bench to Bedside 2013; 164-174 doi:10.2217/9781780841748
• *3Wüthrich, P and Changlin M. "Aquaretic Treatment in 1xbet 신청." The New England Journal of Medicine; 2012, 367 (25): 2440-2441
• *4Torres, VE et al. "Tolvaptan in Patients with Autosomal Dominant 1xbet 신청." The New England Journal of Medicine, 2012: 367 (25): 2407-2418
• *5Patel V, et al. "Advances in the Pathogenesis and Treatment of 1xbet 신청" University of Texas, Department of Pediatrics 2009
• *6Ahrabi, A, et al. "PKD1 Haploinsufficiency Causes a Syndrome of Inappropriate Antidiuresis in Mice" Journal of the American Society of Ne1xbet 신청rology 2007; 18: 1740-1753
• *7Elhassan E, et al. "Progress on Autosomal Dominant 1xbet 신청." The Arab Journal of Nephrology and Transplantation 2009; 2(2): 27-44