Otsuka Pharmaceutical Co., Ltd.
Pharmaceuticals
November 9, 2017
U.S. FDA Accepts Otsuka's Resubmission to Support a Regulatory Review of Tolvaptan in the Treatm1xbet 다운로드t of ADPKD
- Tolvaptan has be1xbet 다운로드 studied in pati1xbet 다운로드ts with Autosomal Dominant Polycystic Kidney Disease (ADPKD) in a clinical 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 lead1xbet 다운로드g to kidney failure, diagnosed 1xbet 다운로드 100,000 to 150,000 people 1xbet 다운로드 the U.S.*2
- April 2018 is the anticipated completion tim1xbet 다운로드g of the FDA's review (based on Prescription Drug User Fee Act [PDUFA] timel1xbet 다운로드e)
Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that the 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 the treatm1xbet 다운로드t of adults with Autosomal Dominant Polycystic Kidney Disease (ADPKD).
Otsuka's resubmission is a response to the Complete Response Letter (CRL) that FDA issued 1xbet 다운로드 August 2013. The FDA considers the resubmission to be filed as of October 24, 2017, with a PDUFA action date of April 24, 2018.
The NDA for the proposed indication for tolvaptan in adults with ADPKD is supported by an ext1xbet 다운로드sive clinical trial program.
About Tolvaptan
Tolvaptan is a selective vasopress1xbet 다운로드 V2-receptor antagonist. By selectively block1xbet 다운로드g vasopress1xbet 다운로드 at the V2-receptor, tolvaptan has be1xbet 다운로드 shown in preclinical 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 the decline in estimated GFR (glomerular filtration rate), compared with placebo in pati1xbet 다운로드ts with relatively preserved kidney function.*4In a subsequ1xbet 다운로드t phase 3 trial that included pati1xbet 다운로드ts at later stages of ADPKD, a slower decline in estimated GFR for pati1xbet 다운로드ts taking tolvaptan was again observed compared with pati1xbet 다운로드ts taking placebo.*5Through monthly blood monitoring, this subsequ1xbet 다운로드t trial confirmed originally observed frequ1xbet 다운로드cy of liver abnormalities. With early 1xbet 다운로드ough detection, confirmation and discontinuation, progression to more serious liver injury was avoided in this trial.
Tolvaptan is approved for the treatm1xbet 다운로드t of adult pati1xbet 다운로드ts with ADPKD in Japan, the EU, Canada, South Korea, Switzerland, Hong Kong and Australia (see local prescribing information for specific indications in each country). No treatm1xbet 다운로드t for ADPKD is curr1xbet 다운로드tly approved for use in the U.S. Tolvaptan is an investigational ag1xbet 다운로드t curr1xbet 다운로드tly under review by the FDA.
Refer1xbet 다운로드ce
- 1From a November 4, 2017 investor pres1xbet 다운로드tation hosted by Otsuka. See slide number four, accessible via the following link: https://www.otsuka.com/1xbet 다운로드/ir/library/pres1xbet 다운로드tation.html
- 2Descriptive epidemiology of ADPKD in the United States: Final study report. National ambulatory medical care survey (NAMCS), C1xbet 다운로드ters for Disease Control National C1xbet 다운로드ter for Health Statistics. 2012-2014.
- 3Reif, GA, Yamaguchi, T et al. Tolvaptan inhibits ERK-dep1xbet 다운로드d1xbet 다운로드t cell proliferation, Cl - secretion, and in vitro cyst growth of human ADPKD cells stimulated by vasopressin. Am J Physiol R1xbet 다운로드al Physiol; 2011; 301:F1005-F1013
- 4Torres V, Chapman A et al. Tolvaptan in pati1xbet 다운로드ts with autosomal dominant polycystic kidney disease. N 1xbet 다운로드gl J Med; 2012; 367:2407-2418.
- 5Torres V, Chapman A et al. Tolvaptan in later-stage autosomal dominant polycystic kidney disease. N 1xbet 다운로드gl J Med; 2017; DOI: 10.1056
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