 The study compared Xarelto, also known as rivaroxaban, with older
drug warfarin for the prevention of stroke and systemic embolisms in
patients with a type of irregular heartbeat that is common among the
elderly."Due to the defect it is now thought that the INR
(international normalized ratio) device may have impacted the
clotting results in some patients in the warfarin group," the
European Medicines Agency said in a statement, adding it will
publish the results when the investigation is complete.
An INR device measures from a patient's blood sample how quickly
it starts clotting.
Bayer and Duke University's Clinical Research Institute, which
conducted some of the trial work and which used the device in
question, said they had each concluded from their analyses that the
faulty device did not have an effect on the overall trial results.
"The findings from the (secondary) analysis are consistent with
the results from the original trial and do not alter the
conclusions," Duke said in a statement on its website.
Bayer chalked up 1.68 billion euros ($1.83 billion) in revenue
from Xarelto in 2014, mainly from its use in stroke prevention, and
revenue was 1.60 billion in the first nine months of 2015, up 38
percent from a year earlier, making it Bayer's best-selling drug.
The investigation into the device hit Bayer's shares, which were
2.6 percent lower by 0810 GMT, making them the biggest faller in
Germany's blue-chip index.
Analysts at Kepler Cheuvreux and Equinet said the impact would
likely be very limited.
"Given that ... probably hundreds of different devices were used to
assess the control group patients, a single defective device is
unlikely to have a statistically relevant effect on the overall
outcome," Kepler Cheuvreux's Fabian Wenner said.
[to top of second column] |
The U.S. Food and Drug Administration said it was "aware of
concerns regarding the INR device and its use in the Rocket AF
trial and is reviewing relevant data".
"Bayer is working closely with health authorities to address any
questions they may have," a spokeswoman said in an emailed
statement. "Study after study continues to confirm that Xarelto is
performing as expected with a positive benefit-risk profile."
The investigation was first reported by German daily Handelsblatt.
Stroke prevention pill Xarelto, jointly developed and marketed
with Bayer's partner Johnson & Johnson, competes with Bristol
Myers-Squibb and Pfizer's Eliquis. Bayer said at the end of October
that Xarelto has a 34 percent market share globally.
(Reporting by Victoria Bryan, Till Weber and Ludwig Burger;
Editing by Greg Mahlich and Jane Merriman)
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