Johnson & Johnson: Third Time’s Not the Charm for Expanded Xarelto Approval
The news hardly comes as a surprise, given recent reports, but it seems that, as many analysts predicted, Johnson & Johnson (NYSE:JNJ) has failed to win FDA approval for the expanded use of a blood-thinning drug, Xarelto, a U.S. advisory panel announced Thursday, according to Bloomberg.
The drug is already used as a preventative medicine for patients with pulmonary deep vein thrombosis, pulmonary embolism, and to reduce the risk of stroke and blood clots in people with irregular heartbeats not due to heart problems, but the company was hoping to expand the drug’s use to include patients who have previously had heart attacks and other complications due to acute coronary syndrome (or, ACS), as previously reported. ACS is a term that covers a range of conditions that bring about a sudden reduction of blood supply to the heart, including heart attacks.
The FDA advisory panel voted 10-0 that Xarelto should not be used to help prevent heart attacks and strokes 90 days after patients experience severe chest pain, or ACS, reports Bloomberg. The vote, announced Thursday, marks the third time Johnson & Johnson has attempted to gain FDA approval for patients with chest pains and other heart problems.