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.

Much of the FDA panel’s skepticism was due to poor data quality; the company was missing follow-up data for 400 patients who had taken the drug, a number that panelist Sanjay Kaul, a cardiologist at Cedars-Sinai Medical Center in Los Angeles called “intolerable,” Bloomberg reports. “It’s not just that the data are fragile, it’s that the therapy has both benefits and harms and in that context the quality of the data becomes increasingly important,” another panelist, Steven Nissen, who currently serves as Chair of the Department of Cardiovascular Medicine at the Cleveland Clinic Foundation said during the meeting.

The drug is an attempt by Johnson & Johnson to replace a 50-year-old standby drug, wafarin, that is commonly used to treat patients with ACS. The company isn’t the first to try to gain approval for such as drug: competitors Bristol-Myers Squibb Co. (NYSE:BMY), Pfizer Inc. (NYSE:PFE), and Boehringer Ingelheim GmbH all have similar medicines in development.

Xarelto was originally approved in 2011 to treat blood clots in patients undergoing hip and knee surgeries, but this most recent denial is only one of several the FDA has delivered; in both 2012 and 2013 the FDA rejected the use of Xarelto as a treatment for ACS patients. Xarelto has, however, been approved for the prevention of heart attacks and strokes in Europe, as of May, 2013.