The European
Commission (EC) today approved Boehringer Ingelheim’s breakthrough oral
anticoagulant, Pradaxa(R) (dabigatran etexilate) for the prevention of stroke
in patients with atrial fibrillation (AF) at risk of stroke. This EU label
extension means that, for the first time in over 50 years, millions of AF
patients across Europe will have access to a
new treatment for the prevention of AF-related strokes which is effective and
convenient, and has demonstrated a good safety profile.

The EC has approved the use of dabigatran etexilate in the
EU for the prevention of stroke and systemic embolism in adult patients with non-valvular
AF with one or more risk factors. While overall the 150mg bid dose is
recommended for the majority of patients, the 110mg bid dose is specifically
available for elderly patients aged 80 years or above, for patients at
increased risk of bleeding and for patients who are co-administered with
dabigatran etexilate and the calcium channel blocker verapamil.

In 2008 dabigatran etexilate was granted EU approval for the
primary prevention of venous thromboembolic events (blood clots) in adults who have
undergone elective total hip or elective total knee replacement surgery.
Speaking of the new EU label extension for the prevention of stroke in patients
with AF, Professor Gregory Lip, Consultant Cardiologist & Professor of
Cardiovascular Medicine, University of
Birmingham Centre
for Cardiovascular Sciences, Birmingham, United Kingdom commented, “The approval of
dabigatran etexilate in Europe represents a
major advance in the treatment of this condition. For the past 50 years
physicians worldwide have been waiting for an alternative to vitamin K
antagonist therapies, such as long time standard of care, warfarin.” He
continued, “Whilst effective, warfarin has many limitations such as the
need for regular monitoring and various food-drug and drug-drug interactions,
resulting in only half of eligible patients receiving warfarin and fewer than
half of these patients being controlled within the desired therapeutic
range.” Trudie Lobban, CEO of the Atrial Fibrillation Association added, “Atrial
fibrillation raises the risk of stroke by five times, resulting in up to three
million people worldwide suffering strokes related to this condition each year.
Atrial fibrillation-related strokes are particularly severe and disabling, with
one half of this population dying within one year after a stroke.” The
approval of dabigatran etexilate for stroke prevention in AF patients is based
on the groundbreaking results from RE-LY(R), one of the largest studies ever
conducted in AF including over 18,000 patients. RE-LY(R) was a PROBE
(prospective, randomized, open-label with blinded endpoint evaluation) trial,
comparing two fixed doses of the oral direct thrombin inhibitor dabigatran
etexilate (110mg and 150mg bid) each administered in a blinded manner, with
open label warfarin. Dabigatran etexilate 150mg bid is the only novel oral
anticoagulant approved for stroke prevention in AF in Europe
that has been proven superior to well-controlled warfarin (median TTR 675.
Dabigatran etexilate 150mg bid reduced the risk of stroke and systemic embolism
by 35% while also significantly lowering the risk of life-threatening and
intracranial bleeding, compared to well-controlled warfarin. Dabigatran
etexilate 110mg bid has been shown non-inferior to warfarin in reducing the
risk of stroke and systemic embolism with a significantly lower rate of major
bleeding.

Dr. Stuart Connolly, co-principal investigator of RE-LY(R),
Director, Division of Cardiology at McMaster
University and member of
The Population Health Research Institute, Hamilton,
Ontario added, “The landmark
RE-LY(R) study results also showed us that dabigatran etexilate is consistently
effective at preventing strokes across a wide range of patients with AF,
irrespective of age, gender, stroke risk, type of atrial fibrillation, prior
stroke, and comorbidities such as hypertension and diabetes.” In addition
to the approval in Europe, dabigatran etexilate has already been approved for
the prevention of stroke in atrial fibrillation in the US, Canada,
Japan, Australia and
several other countries across four continents. In 2008 dabigatran etexilate was
granted EU approval for the primary prevention of venous thromboembolic events
(blood clots) in adults who have undergone elective total hip or elective total
knee replacement surgery.

“The approval of dabigatran etexilate in Europe marks an important milestone in the history of
Boehringer Ingelheim and also in the continuing fight for improved prevention
of stroke, a disease which continues to have a large unmet need,” said
Professor Andreas Barner,Chairman of the Board of Managing Directors,
Boehringer Ingelheim. “It is a result of nearly 20 years of innovative
research and development by our scientists. We will now ensure that this new breakthrough
treatment is made available to physicians and atrial fibrillation patients
throughout Europe as soon as possible.”