TOKYO, April 15, 2015 /PRNewswire/ --
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo)
today announced that Swissmedic, the regulatory authority of
Switzerland, has granted approval
of Lixiana® (edoxaban), an oral, once-daily selective factor Xa
inhibitor, for the prevention of stroke and systemic embolism (SE)
in adult patients with non-valvular atrial fibrillation (NVAF).
Simultaneously, Lixiana® has received marketing authorisation in
Switzerland for the treatment of
adult patients with venous thromboembolism (VTE), including deep
vein thrombosis (DVT) and pulmonary embolism (PE), following
previous treatment with fractionated or unfractionated heparin for
five days, as well as for the prevention of recurrent
VTE.[1]
"Lixiana is an important new anticoagulant for physicians and
their patients with NVAF and VTE," said Glenn Gormley, MD, PhD, Senior Executive Officer
and Global Head of R&D, Daiichi Sankyo Company, Limited and
Executive Chairman and President, Daiichi Sankyo, Inc. "The
approval of Lixiana in Switzerland
marks Daiichi Sankyo's first opportunity to make once-daily
edoxaban available in a European country, and illustrates the
Company's commitment to providing new treatment options to patients
with cardiovascular diseases with significant unmet needs."
The approved indications in Switzerland for Lixiana are based on data from
the phase 3 ENGAGE AF-TIMI 48 and Hokusai-VTE studies, the largest
and longest single comparative global trials of a novel oral
anticoagulant in patients with NVAF or acute VTE, involving 21,105
and 8,292 patients, respectively.[2],[3]
In the ENGAGE AF-TIMI 48 study, once-daily edoxaban 60 mg
demonstrated non-inferiority to warfarin, for the primary efficacy
endpoint of occurrence of stroke or SE in patients with NVAF (1.18%
vs. 1.50% per year, respectively; hazard ratio [HR], 0.79; 97.5%
confidence interval [CI], 0.63 to 0.99, p<0.001). In addition,
once-daily edoxaban 60 mg demonstrated a significant 20% risk
reduction of major bleeding in patients with NVAF compared to
warfarin (2.75% vs. 3.43% per year, respectively; HR, 0.80; 95% CI,
0.71 to 0.91, p<0.001).[2]
In the Hokusai-VTE study, once-daily edoxaban 60 mg was
non-inferior to warfarin for the primary efficacy endpoint of
recurrence of symptomatic VTE (3.2% vs. 3.5% of patients,
respectively; HR, 0.89; 95% CI, 0.70 to 1.13, p<0.001). In
addition, edoxaban demonstrated a significant 19% risk reduction of
clinically relevant bleeding in patients with VTE compared to
warfarin (8.5% vs. 10.3% of patients, respectively; HR, 0.81; 95%
CI, 0.71 to 0.94, p=0.004).[3]
Atrial fibrillation (AF) is the most common type of heart rhythm
disorder, and is associated with substantial morbidity and
mortality.[4] More than 80,000 people in
Switzerland suffer from AF, and
true prevalence may be higher as up to one third of AF patients do
not present with symptoms and go undiagnosed.[5] More
than six million Europeans are diagnosed with AF, and this figure
is expected to at least double over the next 50
years.[6],[7] One in five of all strokes are
as a result of AF.[6]
VTE is a major cause of morbidity and
mortality.[8] VTE is a major health problem
in Europe, with over one million
VTE events or deaths per year (France, Germany, Italy, Spain,
Sweden, UK), including more than
370,000 VTE-related deaths.[8]
About Lixiana (edoxaban)
In Switzerland, Lixiana®
(edoxaban) is indicated for the prevention of stroke and SE in
adult patients with NVAF, and for the treatment of adult patients
with VTE, including DVT and PE, following previous treatment with
fractionated or unfractionated heparin for five days, as well as
for the prevention of recurrent VTE.[1] The recommended
dose of Lixiana is 60 mg once-daily, with a dose reduction to 30 mg
once-daily in patients with moderate or severe renal impairment
(creatinine clearance [CrCL] 15-50 mL/min), body weight ≤ 60 kg, or
concomitant use of certain P-glycoprotein (P-gp) inhibitors
(ciclosporin, dronedarone, erythromycin, ketoconazole, quinidine or
verapamil).[1]
Edoxaban is currently marketed in Japan and the United
States.[9],[10] In the EU and other
countries, regulatory review is ongoing.
About the ENGAGE AF-TIMI 48 Study
ENGAGE AF-TIMI 48 (Effective
aNticoaGulation with factor xA next
GEneration in Atrial Fibrillation) was a
three-arm, randomized, double-blind, double-dummy, global phase 3
clinical trial comparing once-daily edoxaban with warfarin in
21,105 patients with NVAF at moderate-to-high risk of
thromboembolic events at 1,393 centers in 46 countries. ENGAGE
AF-TIMI 48 compared two edoxaban treatment strategies, a higher
dose arm (60 mg or 30 mg dose reduced) once-daily and a lower dose
arm (30 mg or 15 mg dose reduced) once-daily, with warfarin in
patients with NVAF for a median of 2.8 years follow-up. Patients
were dose reduced for creatinine clearance (CrCL) 30 to 50 mL/min,
body weight of 60 kg or less or certain p-glycoprotein inhibitor
use. ENGAGE AF-TIMI 48 represents the largest and longest single
comparative global trial with a novel anticoagulant in patients
with NVAF performed to date.[2] The full results were
presented at the AHA Scientific Sessions 2013 in Dallas and published in the New
England Journal of Medicine.
About the Hokusai-VTE Study
Hokusai-VTE was a global, event-driven, randomized,
double-blind, double-dummy, parallel-group phase 3 clinical study
involving 8,292 patients in 439 clinical sites across 37 countries
to evaluate once-daily edoxaban in patients with either acute
symptomatic DVT, PE or both. The Hokusai-VTE study was designed to
reflect clinical practice using a flexible treatment duration of
3-12 months in a broad spectrum of VTE patients, including initial
use of parenteral anticoagulant (heparin) for 5-10 days, the proven
global standard of care. Patients were randomized to receive
edoxaban 60 mg once-daily (dose reduced to 30 mg for CrCL 30 to 50
mL/min, body weight of 60 kg or less, or certain p-glycoprotein
inhibitor use) or the comparator, warfarin, following initial
open-label enoxaparin or unfractionated heparin therapy. In the
comparator arm, patients received initial heparin therapy
concurrently with warfarin, titrated to a target INR of 2.0 to 3.0,
followed by warfarin alone. The treatment duration was from 3
months and up to a maximum of one year. The duration of study
treatment was determined by the investigator based on the patient's
clinical features.[3] The full results were
presented at the ESC Congress 2013 in Amsterdam and published in the New England
Journal of Medicine.
About Daiichi Sankyo
Daiichi Sankyo Group is dedicated to the creation and supply of
innovative pharmaceutical products to address the diversified,
unmet medical needs of patients in both mature and emerging
markets. While maintaining its portfolio of marketed
pharmaceuticals for hypertension, dyslipidemia and bacterial
infections used by patients around the world, the Group has also
launched treatments for thrombotic disorders and is building new
product franchises. Furthermore, Daiichi Sankyo research and
development is focused on bringing forth novel therapies in
oncology and cardiovascular-metabolic diseases, including
biologics. The Daiichi Sankyo Group has created a "Hybrid Business
Model," to respond to market and customer diversity and optimize
growth opportunities across the value chain. For more information,
please visit: http://www.daiichisankyo.com.
Forward-looking statements
This press release contains forward-looking statements and
information about future developments in the sector, and the legal
and business conditions of DAIICHI SANKYO Co., Ltd. Such
forward-looking statements are uncertain and are subject at all
times to the risks of change, particularly to the usual risks faced
by a global pharmaceutical company, including the impact of the
prices for products and raw materials, medication safety, changes
in exchange rates, government regulations, employee relations,
taxes, political instability and terrorism as well as the results
of independent demands and governmental inquiries that affect the
affairs of the company. All forward-looking statements contained in
this release hold true as of the date of publication. They do not
represent any guarantee of future performance. Actual events and
developments could differ materially from the forward-looking
statements that are explicitly expressed or implied in these
statements. DAIICHI SANKYO Co., Ltd. assume no responsibility for
the updating of such forward-looking statements about future
developments of the sector, legal and business conditions and the
company.
References
- Lixiana® (edoxaban) Prescribing Information. Daiichi Sankyo
(Switzerland) AG. 2015.
- Giugliano R, et al. Edoxaban versus warfarin in patients with
atrial fibrillation. N Engl J Med.
2013;369(22):2093-2104.
- Büller H, et al. Edoxaban versus warfarin for the treatment of
symptomatic venous thromboembolism. N Engl J
Med. 2013;369(15):1406-1415.
- Iqbal MB, et al. Recent developments in atrial
fibrillation. BMJ. 2005;330(7485):238-43.
- Pavlovic N, et al. Atrial fibrillation - European and Swiss
perspectives. Cardiovasc
Med. 2014;17(6):167-170.
- Camm A, et al. Guidelines for the management of atrial
fibrillation: the Task Force for the Management of Atrial
Fibrillation of the European Society of Cardiology
(ESC). Eur Heart J. 2010;31(19):2369-2429.
- Krijthe BP, et al. Projections on the number of individuals
with atrial fibrillation in the European Union, from 2000 to
2060. Eur Heart
J. 2013;34(35):2746-2751.
- Cohen A, et al. Venous thromboembolism (VTE) in
Europe. Thromb Haemost. 2007;98(4):756-764.
- Daiichi Sankyo press release - Daiichi Sankyo Launches New
Formulation of LIXIANA® 60 mg Tablets (edoxaban) in Japan. 8 Dec
2014. Available
at:http://www.daiichisankyo.com/media_investors/media_relations/press_releases/detail/006226.html.
[Last accessed: April 2015].
- Daiichi Sankyo press release - SAVAYSA™ (edoxaban) Now
Available in U.S. Pharmacies. 9 February
2015. Available
at:http://www.daiichisankyo.com/media_investors/media_relations/press_releases/detail/006247.html.
[Last accessed: April 2015].
Contact
Daria Munsel (European Media)
Daiichi Sankyo Europe GmbH
Edoxaban Comm. & Product PR Europe
Phone: +49-89-7808728
Sandra Lingk (Germany, Austria, Switzerland Media)
Daiichi Sankyo Deutschland GmbH
Product PR Manager DACH
Phone: +49-89-7808732
