FDA Review Suggests Skepticism of Johnson & Johnson Drug’s Efficacy
An FDA review of Johnson & Johnson‘s (NYSE:JNJ) anticoagulant drug, Xarelto, is markedly less-than-favorable. The report, which was released Tuesday, is skeptical as to whether the company’s data proves that the drug could find a new application in reducing the risk of further heart problems in patients who have already had a heart attack, Reuters reports. The FDA review comes two days before outside experts are scheduled to meet to discuss the drug’s new, proposed application and decided whether it should be approved.
Xarelto is already used as a preventative medicine for a number of different conditions, including the prevention of pulmonary deep vein thrombosis, pulmonary embolisms, and also to help reduce the risk of stroke and blood clots in patients with an irregular heart beat that is not caused by heart problems.
The company is hoping that the drug will also be approved for use as a preventative medicine for patients with acute coronary syndrome (or, ACS), a term that covers any condition that brings about sudden reduced blood flow to the heart, including heart attacks and chest pains, and claims that Xarelto, which is also known as rivaroxaban, should be used in the first 90 days after suffering a heart attack.