SILVER SPRING, Md. -- The FDA has declined to approve a new indication for rivaroxaban (Xarelto) for patients with acute coronary syndrome, the drug's manufacturer announced.
The Janssen unit of Johnson & Johnson did not say what the FDA told the company in the so-called complete response letter outlining the agency's reasoning.
The FDA does not release the letters, leaving it up to drug sponsors to describe the contents at their discretion.
However, in a 6-4 vote last month, an FDA advisory committee recommended against approval, with some panel members expressing concern about risks of bleeding associated with rivaroxaban.
The committee also was put off by data missing from the ATLAS ACS trial that was the foundation for Janssen's application.
Top-line results indicated that the drug, when added to conventional anti-platelet therapy, reduced rates of a composite of cardiovascular death, MI, and stroke compared with anti-platelet therapy alone in ACS patients.
But data were missing on more than 2,400 patients who withdrew from the trials, and follow-up in some patients was incomplete. FDA staff reviewers had also complained about deaths that had gone uncounted.
In announcing the complete response letter, Janssen said it remained confident in the ATLAS ACS results. "We will continue to work with the FDA to fully address their questions as quickly as possible," a company official said in a statement.
Rivaroxaban is already approved for prevention of stroke in patients with nonvalvular atrial fibrillation and for prevention of deep vein thrombosis in patients undergoing joint replacement surgery.