The U.S. Food and Drug Administration has declined to approve Johnson & Johnson (NYSE:JNJ) drug Xarelto to reduce the risk of secondary cardiovascular events in patients with acute coronary syndrome, such as myocardial infarction and stroke, until questions raised by the regulator are addressed. The news follows an FDA committee move last month to recommend against approval in a close vote.
The drug developed by J&J’s drug development arm Janssen along with Bayer (NYSE:BAYRY) is already approved for three clinical uses in the U.S.: to reduce the risk of blood clots in the legs and lungs of people who have just had knee replacement surgery; to reduce the risk of blood clots in people recovering from hip replacement surgery; and to reduce the risk of both hemorrhagic and thrombotic strokes and other blood clots in people with atrial fibrillation not caused by a heart valve problem, according to a company statement.
Media reports following the no vote last month cited committee members complaining that there wasn’t enough data.
“I want to see better evidence that this strategy of adding (Xarelto) … is robustly better for the patient,” said Dr. Steven Nissen, panel member and chairman of cardiovascular medicine at the Cleveland Clinic. “And I just wasn’t convinced.”Advertisement
Bleeding issues also played a role in the 6-4 vote (with one abstention). The drug was found to increase the risk of major bleeding and intracranial hemorrhage, although not the risk of fatal bleeding.
Dr. Paul Burton, of Raritan, New Jersey-based Janssen R&D said it would continue to work with the FDA to address their questions as quickly as possible.