Bayer Halts Phase 3 Study on New Xarelto Indication
October 06 2017 - 1:58AM
Dow Jones News
By Sarah Sloat
Bayer AG (BAYN.XE) said late Thursday it halted a phase 3 study
for the use of blood-thinning drug Xarelto in a further indication
because it didn't show improved efficacy compared with another
treatment using aspirin.
The Navigate Esus study was testing Xarelto for the secondary
prevention of strokes and systemic embolism in patients who
recently had an embolic stroke of undetermined source.
Researchers stopped the trial early because the Xarelto and
aspirin arms of the study showed comparable efficacy, and there was
little chance of an overall benefit if it were completed, the
German pharmaceutical and chemicals company said.
"While bleeding rates were low overall, an increase in bleeding
was observed in the [Xarelto] arm compared to the low-dose aspirin
arm," Bayer said.
Xarelto, also known as rivaroxaban, is a prescription
anticoagulant which been approved for seven indications. The drug
contributed just over 2.9 billion euros ($3.4 billion) in sales to
Bayer's pharmaceutical division last year.
The drug was developed jointly by Bayer and Janssen
Pharmaceuticals, a unit of Johnson & Johnson (JNJ). It is
marketed outside the U.S. by Bayer and within the U.S. by
Janssen.
Write to Sarah Sloat at sarah.sloat@wsj.com
(END) Dow Jones Newswires
October 06, 2017 02:43 ET (06:43 GMT)
Copyright (c) 2017 Dow Jones & Company, Inc.
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