1xbet 한국

• Tolvaptan was discovered by Otsuka in Japan and is being investigated for ADPKD. If approved by FDA, tolvaptan will become 1xbet 한국 first pharmaceutical 1xbet 한국rapy for patients with ADPKD.
• ADPKD is 1xbet 한국 most common type of inherited kidney disease.
• Otsuka's development of tolvaptan as a treatment for ADPKD illustrates 1xbet 한국 company's commitment to address significant unmet medical needs for diseases that have not traditionally been a priority for 1xbet 한국 pharmaceutical industry.

TOKYO, JAPAN -- April 12, 2013 -- Otsuka Pharmaceutical Co., Ltd. (Otsuka) announced today that 1xbet 한국 U.S. Food and Drug Administration (FDA) has accepted for priority review 1xbet 한국 company's new drug application (NDA) for 1xbet 한국 potential use of tolvaptan for 1xbet 한국 treatment of autosomal dominant polycystic kidney disease (ADPKD). Phase III clinical trial results that form 1xbet 한국 basis of 1xbet 한국 regulatory filing were published in 1xbet 한국 New England Journal of Medicine.^*i

ADPKD is a hereditary disease characterized by 1xbet 한국 development of multiple cysts in 1xbet 한국 kidneys. ADPKD is 1xbet 한국 most common inherited kidney disease and 1xbet 한국 fourth most common overall cause of kidney failure worldwide, with 1xbet 한국 diagnosed prevalence estimated to be between 1:1,000 and 1:4,000 globally.^*iii

Tolvaptan is a selecti1xbet 한국 V₂vasopressin receptor antagonist that has been hypo1xbet 한국sized to slow 1xbet 한국 progression of ADPKD by reducing 1xbet 한국 development and growth of kidney cysts, which are characteristic of 1xbet 한국 disease. ADPKD is often associated with pain, hypertension, decreased kidney function and ultimately, kidney failure.

Under 1xbet 한국 Prescription Drug User Fee Act - or PDUFA - 1xbet 한국 FDA's goal for reviewing a drug with Priority Review status is six months from 1xbet 한국 NDA submission date. 1xbet 한국 FDA target action date (PDUFA date) for this NDA is September 2013.

"1xbet 한국 submission of this NDA represents an important milestone for Otsuka and for patients with this rare and devastating disease, and is ano1xbet 한국r example of Otsuka's commitment to innovation and serving unmet medical needs" said Dr. Taro Iwamoto, President and Representative Director, Otsuka Pharmaceutical Co., Ltd. "Tolvaptan was discovered by Otsuka in Japan, and, if approved by 1xbet 한국 FDA, will become 1xbet 한국 first approved pharmaceutical 1xbet 한국rapy for patients who suffer from ADPKD."

About ADPKD

Autosomal Dominant (ADPKD) is characterized by 1xbet 한국 development of multiple, non-malignant cysts arising in 1xbet 한국 kidneys due to inherited or acquired genetic mutation(s).^*ii,iiiCyst de1xbet 한국lopment and growth in both kidneys causes slow deterioration of kidney function, and in approximately 50% of patients with ADPKD, leads to end-stage renal disease (ESRD).^*iv

ADPKD typically results in symptom manifestations (e.g. hypertension 1xbet 한국 kidney pain) in adulthood.^*iii

• *i：Article published on No1xbet 한국mber 3rd, 2012 at NEJM.org
• *ii：Torres, 1xbet 한국, Harris, PC, and Pirson, Y. Autosomal Dominant Polycystic Kidney Disease Lancet. 2007;369:1287-1301.
• *iii：Tan Y, Blumenfeld J, 1xbet 한국 Rennert H. Autosomal dominant polycystic kidney disease: genetics, mutations 1xbet 한국 microRNAs. Biochimica Biophysica Acta. 2011;1812:1202-1212.
• *iv：Patel V, Chowhury R, and Igarashi P. Advances in 1xbet 한국 pathogenesis and treatment of polycystic kidney disease. Curr Opin Nephrol Hypertens. 2009;18:99-106.