FDA Accepts Otsuka's Resubmission to Support a Regulatory Review of Tolvaptan in the Treatment of ADPKD
09 Novembre 2017 - 1:00PM
Business Wire
- Tolvaptan has been studied in patients
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
trialsi
- ADPKD is a progressive disease leading
to kidney failure, diagnosed in 100,000 to 150,000 people in the
U.S.ii
- April 2018 is the anticipated
completion timing of the FDA’s review (based on Prescription Drug
User Fee Act [PDUFA] timeline)
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 treatment of adults with
Autosomal Dominant Polycystic Kidney Disease (ADPKD).
Otsuka’s resubmission is a response to the Complete Response
Letter (CRL) that FDA issued in 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 extensive clinical trial program.
About Tolvaptan
Tolvaptan is a selective vasopressin V2-receptor antagonist. By
selectively blocking vasopressin at the V2-receptor, tolvaptan has
been shown in preclinical trials to decrease cyst-cell
proliferation and fluid secretion, ultimately reducing cyst
growth.iii
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 patients with relatively preserved kidney
function.iv 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 compared with patients
taking placebo.v Through monthly blood monitoring, this subsequent
trial confirmed originally observed frequency of liver
abnormalities. With early enough detection, confirmation and
discontinuation, progression to more serious liver injury was
avoided in this trial.
Tolvaptan is approved for the treatment of adult patients 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 treatment for ADPKD is currently
approved for use in the U.S. Tolvaptan is an investigational agent
currently under review by the FDA.
About Otsuka
Otsuka Pharmaceutical Company is a global healthcare company
with the corporate philosophy: “Otsuka-people creating new products
for better health worldwide.” Otsuka researches, develops,
manufactures and markets innovative products, with a focus on
pharmaceutical products to meet unmet medical needs and
nutraceutical products for the maintenance of everyday health.
In pharmaceuticals, Otsuka is a leader in the challenging area
of mental health and also has research programs on several
under-addressed diseases including tuberculosis, a significant
global public health issue. These commitments illustrate how Otsuka
is a “big venture” company at heart, applying a youthful spirit of
creativity in everything it does.
Otsuka Pharmaceutical Company is a subsidiary of Otsuka Holdings
Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of
companies employed 45,000 people worldwide and had consolidated
sales of approximately USD 11 billion in 2016.
All Otsuka stories start by taking the road less travelled.
Learn more about Otsuka Pharmaceutical Company on its global
website at https://www.otsuka.co.jp/en. Learn more about Otsuka in
the U.S. at www.otsuka-us.com and connect with us on Twitter at
@OtsukaUS.
_________________
i
From a November 4, 2017 investor
presentation hosted by Otsuka. See slide number four, accessible
via the following link:
https://www.otsuka.com/en/ir/library/presentation.html
ii Descriptive epidemiology of ADPKD in the United States: Final
study report. National ambulatory medical care survey (NAMCS),
Centers for Disease Control National Center for Health Statistics.
2012-2014. iii Reif, GA, Yamaguchi, T et al. Tolvaptan inhibits
ERK-dependent cell proliferation, Cl – secretion, and in vitro cyst
growth of human ADPKD cells stimulated by vasopressin. Am J Physiol
Renal Physiol; 2011; 301:F1005-F1013 iv Torres V, Chapman A et al.
Tolvaptan in patients with autosomal dominant polycystic kidney
disease. N Engl J Med; 2012; 367:2407-2418. v Torres V, Chapman A
et al. Tolvaptan in later-stage autosomal dominant polycystic
kidney disease. N Engl J Med; 2017; DOI: 10.1056
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Otsuka Contacts(Media outside the U.S)Otsuka
Pharmaceutical Co., Ltd.Jeffrey Gilbert, 81-3-6361-7379Leader,
Pharmaceutical Public RelationsGilbert.jeffrey@otsuka.jpor(Media in
the U.S.)Otsuka America Pharmaceutical, Inc.Melanie Deck,
1-609-535-9032Corporate
Communicationsmelanie.deck-cw@otsuka-us.comor(Investors)Otsuka
Holdings Co., Ltd.Yoko Ishii, 81-3-6361-7411Ishiiyo@Otsuka.jp