* Drug awaiting U.S. approval decision by March 17
* Eliquis seen as future multibillion-dollar seller
* Pfizer, Bristol-Myers shares up slightly
By Bill Berkrot
Nov 20 European health regulators on Tuesday
approved an eagerly anticipated blood thinner developed by
Bristol-Myers Squibb Co and Pfizer Inc for
preventing strokes and blood clots in patients with an irregular
heartbeat known as atrial fibrillation, the companies said.
The drug Eliquis, also known as apixaban, is widely
considered one of the most important new products for the two
U.S. drugmakers, with multibillion-dollar annual sales
The European approval was expected after an advisory panel
this year recommended it for atrial fibrillation.
"It's not unexpected, but it's positive to finally get an
afib approval under the belt for Eliquis," said MKM Partners
analyst Jon Lecroy, who sees annual sales reaching $2 billion by
about 2017. "We're looking for a March approval or earlier in
the U.S. for the same indication," he added.
The U.S. Food and Drug Administration is expected to decide
on the proposed use of the drug in the world's biggest market by
March 17, after delaying a decision in June to review more
information from clinical trials.
The European Commission approval marks the first regulatory
approval for Eliquis for stroke prevention in atrial
fibrillation patients in any market, the companies said.
Eliquis belongs to a new class of medicines designed to
replace decades old warfarin for preventing blood clots in heart
patients and after hip or knee replacement surgery.
It already was approved in 27 European Union countries for
prevention of certain blood clots called venous thromboembelisms
following elective hip or knee replacement surgery.
But atrial fibrillation, which greatly raises the risk of
strokes, is considered by far the largest and most important use
for the new drugs, that include Xarelto from Bayer
and Johnson & Johnson, and Pradaxa from privately held
Eliquis, like Xarelto, works by inhibiting a protein called
Factor Xa that plays a critical role in blood clotting. Pradaxa
has a slightly different mechanism of action.
About 6 million people in Europe and another 5.8 million in
the United States suffer from atrial fibrillation, the most
common form of heart arrhythmia, or irregular heartbeat.
In clinical trials, Eliquis demonstrated superiority over
warfarin in reducing the risk of strokes, major bleeding and
Warfarin, widely used for more than half a century, is
inexpensive and works well, but requires close and regular
patient monitoring as well as lifestyle and dietary changes that
are not necessary with the newer medicines.
"Patients with atrial fibrillation have a five times greater
risk of stroke and there remains a critical public health need
for improved treatment options to reduce this risk," Lars
Wallentin, director of cardiology at Uppsala Clinical Research
Centre and University Hospital in Sweden, said in a statement.
He called Eliquis "an important new treatment option for
health care professionals, who now have an oral anticoagulant
with superior outcomes versus warfarin."
Wall Street analysts have said that, based on clinical
efficacy and safety data, they believe Eliquis will become the
dominant player in an estimated $10 billion market for the new
blood thinners once it receives U.S. approval.
Pfizer Chief Executive Ian Read, in a statement, said he
believes Eliquis "has the potential to transform the standard of
care in stroke prevention in nonvalvular atrial fibrillation".
Pfizer shares were up 5 cents at $24.19 and Bristol-Myers
shares were up 2 cents at $32.05, in afternoon trading on the
New York Stock Exchange.