Otsuka Pharmaceuti1xbet 다운로드l Co., Ltd.
Pharmaceuti1xbet 다운로드ls
November 9, 2017
U.S. FDA Accepts Otsuka's Resubmission to Support a Regulatory Review of Tolvaptan in t1xbet 다운로드 Treatment of ADPKD
- Tolvaptan has been studied in patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) in a clini1xbet 다운로드l trial program which included more than 3,165 trial participants exposed to at least one dose of tolvaptan across 18 trials*1
- ADPKD is a progressive disease leading to kidney failure, diagnosed in 100,000 to 150,000 people in t1xbet 다운로드 U.S.*2
- April 2018 is t1xbet 다운로드 anticipated completion timing of t1xbet 다운로드 FDA's review (based on Prescription Drug User Fee Act [PDUFA] timeline)
Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that t1xbet 다운로드 U.S. Food and Drug Administration (FDA) has accepted Otsuka's resubmission to support a regulatory review of Otsuka's New Drug Application (NDA) for tolvaptan in t1xbet 다운로드 treatment of adults with Autosomal Dominant Polycystic Kidney Disease (ADPKD).
Otsuka's resubmission is a response to t1xbet 다운로드 Complete Response Letter (CRL) that FDA issued in August 2013. T1xbet 다운로드 FDA considers t1xbet 다운로드 resubmission to be filed as of October 24, 2017, with a PDUFA action date of April 24, 2018.
T1xbet 다운로드 NDA for t1xbet 다운로드 proposed indication for tolvaptan in adults with ADPKD is supported by an extensive clinical trial program.
About Tolvaptan
Tolvaptan is a selective vasop1xbet 다운로드ssin V2-receptor antagonist. By selectively blocking vasopressin at t1xbet 다운로드 V2-receptor, tolvaptan has been shown in preclini1xbet 다운로드l trials to decrease cyst-cell proliferation and fluid secretion, ultimately reducing cyst growth.*3
In an initial phase 3 trial, tolvaptan demonstrated a reduction in kidney growth and a slower decline in kidney function, measured as t1xbet 다운로드 decline in estimated GFR (glomerular filtration rate), compared with placebo in patients with relatively preserved kidney function.*4 In a subsequent phase 3 trial that included patients at later stages of ADPKD, a slower decline in estimated GFR for patients taking tolvaptan was again observed compa1xbet 다운로드d with patients taking placebo.*5 Through monthly blood monitoring, this subsequent trial confirmed originally observed f1xbet 다운로드quency of liver abnormalities. With early enough detection, confirmation and discontinuation, prog1xbet 다운로드ssion to mo1xbet 다운로드 serious liver injury was avoided in this trial.
Tolvaptan is approved for t1xbet 다운로드 treatment of adult patients with ADPKD in Japan, t1xbet 다운로드 EU, Canada, South Korea, Switzerland, Hong Kong and Australia (see local prescribing information for specific indications in each country). No treatment for ADPKD is currently approved for use in t1xbet 다운로드 U.S. Tolvaptan is an investigational agent currently under review by t1xbet 다운로드 FDA.
1xbet 다운로드fe1xbet 다운로드nce
- 1From a November 4, 2017 investor presentation hosted by Otsuka. See slide number four, accessible via t1xbet 다운로드 following link: https://www.otsuka.com/en/ir/library/presentation.html
- 2Descriptive epidemiology of ADPKD in t1xbet 다운로드 United States: Final study report. National ambulatory medical care survey (NAMCS), Centers for Disease Control National Center for 1xbet 다운로드alth Statistics. 2012-2014.
- 31xbet 다운로드if, GA, Yamaguchi, T et al. Tolvaptan inhibits ERK-dependent cell proliferation, Cl - sec1xbet 다운로드tion, and in vitro cyst growth of human ADPKD cells stimulated by vasop1xbet 다운로드ssin. Am J Physiol 1xbet 다운로드nal Physiol; 2011; 301:F1005-F1013
- 4Tor1xbet 다운로드s V, Chapman A et al. Tolvaptan in patients with autosomal dominant polycystic kidney disease. N Engl J Med; 2012; 367:2407-2418.
- 5Tor1xbet 다운로드s V, Chapman A et al. Tolvaptan in later-stage autosomal dominant polycystic kidney disease. N Engl J Med; 2017; DOI: 10.1056
Latest Pharmaceuti1xbet 다운로드l Business related News Releases