INGELHEIM, Germany. - Wednesday, May 28th 2014 [ME NewsWire]
(BUSINESS WIRE) For media outside of the U.S., the UK & Canada only
Boehringer
Ingelheim announced today that the company has reached a comprehensive
settlement of state and federal cases in the U.S. litigation regarding
Pradaxa® (dabigatran etexilate). The settlement enables Boehringer
Ingelheim to focus solely on its mission of improving patients’ lives
and allows the company to avoid the distraction and uncertainty of
lengthy litigation. The settlement was closed at 650 million US Dollar
(appr. 470 million €). It comes after a reaffirmation from the U.S. Food
and Drug Administration (FDA) of the positive benefit-risk profile of
Pradaxa®, when it published the results of a Medicare study of more than
134,000 patients.1
“Time and again the benefits and safety of
Pradaxa® have been confirmed in many clinical trials and in real world
data analyses. This settlement does not change the facts about Pradaxa®
or its importance to patients,” said Andreas Neumann, Head of the Legal
Department and General Counsel, Boehringer Ingelheim worldwide. “From
the time Pradaxa® launched, Boehringer Ingelheim properly advised
healthcare professionals and patients about its benefits and safety,
working closely with US, European and many other regulators to ensure
healthcare professionals and patients had the information they needed.”
Boehringer
Ingelheim is proud of its employees who have worked for years to
research, develop and offer to patients such an important medication as
Pradaxa®. Pradaxa® was the first oral anticoagulant approved in more
than 50 years to reduce the risk of stroke and systemic embolism in
patients with non-valvular atrial fibrillation (NVAF).
“We
continue to stand resolutely behind Pradaxa® and believed from the
outset that the plaintiffs’ claims lacked any merit. Notwithstanding our
strong belief that we would prevail in these lawsuits, this settlement
allows our company to avoid the distraction and uncertainty of
protracted litigation over years and years,” said Andreas Neumann. “The
US litigation system is described by some as a business where lawyers
run advertising campaigns to find clients. Furthermore we have to
consider that juries composed of lay people have to decide about very
difficult scientific matters. All this does not allow reliable
predictions for the outcome of a huge number of individual trials and
that is why we came to the tough decision to settle,” Andreas Neumann
added.
There are approximately 4,000 claims that the company
seeks to resolve with this settlement. Boehringer Ingelheim expects
most, if not all, of the plaintiffs to accept the terms of the
settlement and Boehringer Ingelheim will vigorously defend against those
who do not.
FDA has publicly stated that Pradaxa® 150 mg twice
daily offers a positive benefit-risk profile and provides an important
health benefit when used as directed to reduce the risk of stroke and
systemic embolism in NVAF patients.2 On May 13, 2014, FDA once again
reaffirmed the positive benefit-risk profile of Pradaxa®when used as
directed when it issued a Drug Safety Communication1 that included
results from a Medicare study comparing new users of Pradaxa® and
warfarin who had received a diagnosis of atrial fibrillation. This
included more than 134,000 Medicare patients, who were 65 years of age
or older. The new study found that, among new users of blood-thinning
drugs, Pradaxa® was associated with a lower risk of clot-related
strokes, bleeding in the brain and death compared to warfarin.1 The
study also found an increased risk of major gastrointestinal bleeding
with use of Pradaxa® as compared to warfarin, but unlike in RE-LY®,3,4
no increased risk of MI compared to warfarin.1
Compared to the 50
year-old anticoagulant warfarin, Pradaxa® 150 mg dose taken twice daily
is superior at reducing the risk of ischemic and hemorrhagic strokes
with a comparable rate of bleeding to the warfarin treatment.3,4
Pradaxa® 110 mg dose taken twice daily, which is indicated for certain
patients, was as effective as warfarin at reducing risk of stroke with
lower rates of bleeding.3,4 Moreover, Pradaxa® 150 mg is the only novel
oral anticoagulant which in its pivotal study versus warfarin (RE-LY®*)
showed a superior reduction of ischemic strokes (the most common stroke
for NVAF patients5).3,4
As with any anticoagulant, there needs to
be a balanced consideration of stroke risk reduction and bleeding risk.
Patients should not stop taking their anticoagulant medication without
first talking to their health care providers. Discontinuing
anticoagulation therapy puts a patient at increased risk of stroke.
~ENDS~
Please click on the link below for ‘Notes to Editors’ and ‘References’:
http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2014/28_may_2014_dabigatranetexilate.html
*
RE-LY® was a global, phase III, PROBE (prospective, randomized,
open-label with blinded endpoint evaluation) design trial comparing two
fixed doses of the oral direct thrombin inhibitor Pradaxa® (110mg and
150mg twice daily) each administered in a blinded manner, with open
label warfarin.3,4,6
Contacts
Boehringer Ingelheim GmbH
Judith von Gordon
Phone: +49 6132 – 77 3582
Fax: +49 6132 – 77 6601
E-mail: press@boehringer-ingelheim.com
Twitter: http://twitter.com/Boehringer
More information
www.boehringer-ingelheim.com
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