Bayer AG's (BYR.L,BAYRY.PK,BAYZF.PK) Bayer HealthCare said Wednesday that the U.S. Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee voted against the approval of the oral anticoagulant Xarelto (rivaroxaban) 2.5 mg BID in combination with standard antiplatelet therapy to reduce the risk of secondary cardiovascular events in patients with Acute Coronary Syndrome or ACS.
The panel reportedly rejected the drug for the indication by a 6 to 4 vote with one member being absent. The members were concerned about missing data as well as bleeding risks.
The drug was developed by Bayer and Johnson & Johnson (JNJ). Xarelto is approved in the U.S. to reduce the risk of blood clots in the legs and lungs of people who have just had knee or hip replacement surgery.
It is also used to reduce the risk of both hemorrhagic and thrombotic strokes as well as other blood clots in people with atrial fibrillation not caused by a heart valve problem.
Data presented at the Advisory Committee meeting included results from the pivotal, global Phase III ATLAS ACS 2-TIMI 51 study. This compared oral rivaroxaban dosed twice daily in addition to standard antiplatelet therapy with standard antiplatelet therapy alone in preventing secondary cardiovascular events in patients with ACS.
Bayer fell 2.34 percent on the Xetra at 50.84 euros on a volume of 3.15 million shares.
JNJ closed on Wednesday at $63.27, down 0.39 percent, on 11.27 million shares.
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