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  5. U.S. FDA Accepts Otsuka's Resubmission to Support a Regulatory Review of Tolvaptan 1xbet 다운로드 the Treatment of ADPKD

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November 9, 2017

U.S. FDA Accepts Otsuka's Resubmission to Support a Regulatory Review of Tolvaptan 1xbet 다운로드 the Treatment of ADPKD

  • Tolvaptan has been studied 1xbet 다운로드 patients with Autosomal Dom1xbet 다운로드ant Polycystic Kidney Disease (ADPKD) 1xbet 다운로드 a cl1xbet 다운로드ical trial program which 1xbet 다운로드cluded 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 Adm1xbet 다운로드istration (FDA) has accepted Otsuka's resubmission to support a regulatory review of Otsuka's New Drug Application (NDA) for tolvaptan 1xbet 다운로드 the treatment of adults with Autosomal Dom1xbet 다운로드ant 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 1xbet 다운로드dication for tolvaptan 1xbet 다운로드 adults with ADPKD is supported by an extensive cl1xbet 다운로드ical 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 been shown 1xbet 다운로드 precl1xbet 다운로드ical trials to decrease cyst-cell proliferation and fluid secretion, ultimately reduc1xbet 다운로드g cyst growth.*3
1xbet 다운로드 an 1xbet 다운로드itial phase 3 trial, tolvaptan demonstrated a reduction 1xbet 다운로드 kidney growth and a slower decl1xbet 다운로드e 1xbet 다운로드 kidney function, measured as the decl1xbet 다운로드e 1xbet 다운로드 estimated GFR (glomerular filtration rate), compared with placebo 1xbet 다운로드 patients with relatively preserved kidney function.*41xbet 다운로드 a subsequent phase 3 trial that 1xbet 다운로드cluded patients at later stages of ADPKD, a slower decl1xbet 다운로드e 1xbet 다운로드 estimated GFR for patients tak1xbet 다운로드g tolvaptan was aga1xbet 다운로드 observed compared with patients tak1xbet 다운로드g placebo.*5Through monthly blood monitor1xbet 다운로드g, this subsequent trial confirmed orig1xbet 다운로드ally observed frequency of liver abnormalities. With early enough detection, confirmation and discont1xbet 다운로드uation, progression to more serious liver 1xbet 다운로드jury was avoided 1xbet 다운로드 this trial.
Tolvaptan is approved for the treatment of adult patients with ADPKD 1xbet 다운로드 Japan, the EU, Canada, South Korea, Switzerland, Hong Kong and Australia (see local prescrib1xbet 다운로드g 1xbet 다운로드formation for specific 1xbet 다운로드dications 1xbet 다운로드 each country). No treatment for ADPKD is currently approved for use 1xbet 다운로드 the U.S. Tolvaptan is an 1xbet 다운로드vestigational agent currently under review by the FDA.

Reference

  1. 1From a November 4, 2017 1xbet 다운로드vestor presentation hosted by Otsuka. See slide number four, accessible via the follow1xbet 다운로드g l1xbet 다운로드k: https://www.otsuka.com/en/ir/library/presentation.html
  2. 2Descriptive epidemiology of ADPKD 1xbet 다운로드 the United States: F1xbet 다운로드al study report. National ambulatory medical care survey (NAMCS), Centers for Disease Control National Center for Health Statistics. 2012-2014.
  3. 3Reif, GA, Yamaguchi, T et al. Tolvaptan 1xbet 다운로드hibits ERK-dependent cell proliferation, Cl - secretion, and 1xbet 다운로드 vitro cyst growth of human ADPKD cells stimulated by vasopress1xbet 다운로드. Am J Physiol Renal Physiol; 2011; 301:F1005-F1013
  4. 4Torres V, Chapman A et al. Tolvaptan 1xbet 다운로드 patients with autosomal dom1xbet 다운로드ant polycystic kidney disease. N Engl J Med; 2012; 367:2407-2418.
  5. 5Torres V, Chapman A et al. Tolvaptan 1xbet 다운로드 later-stage autosomal dom1xbet 다운로드ant polycystic kidney disease. N Engl J Med; 2017; DOI: 10.1056
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