Credit: CDC
For a second time, the FDA has decided against approving rivaroxaban (Xarelto) to reduce the risk of cardiovascular events in patients with acute coronary syndrome (ACS).
The agency has issued a complete response letter to the drug’s makers, Janssen Pharmaceuticals.
The contents of the letter are not publicly known, but representatives at Janssen have said they “are evaluating the letter and will respond to the agency’s questions.”
This is not the first time the FDA has raised questions about the use of rivaroxaban in ACS. Last June, the agency issued a complete response letter requesting additional information on the drug.
A month before that, an FDA review committee had expressed concerns about missing follow-up data from the ATLAS ACS 2 TIMI 51 trial (JL Mega et al, NEJM, 2012).
So in September, Janssen supplied the FDA with data on the patients who had withdrawn from trial. The company was able to confirm the vital status information for 843 (63%) of the 1338 trial participants who previously had unknown vital status.
Of those 843 patients, 37 had died. The company said the deaths were equally distributed among the treatment groups—rivaroxaban at 2.5 mg, rivaroxaban at 5 mg, and placebo.
“We remain confident in the robustness and results of the ATLAS ACS 2 TIMI 51 trial, evidenced by a significant reduction in cardiovascular events, including a clinically important decrease in cardiovascular death . . . ,” said Christopher Nessel, Vice President at Janssen.
“While we saw an increase in major bleeding, there was no increase in fatal bleeding. We will continue to work with the FDA to address their questions.”
Rivaroxaban is already approved by the FDA to treat and prevent the recurrence of deep vein thrombosis and pulmonary embolism, as thromboprophylaxis in patients who have undergone knee or hip replacement surgery, as well as to reduce the risk of stroke in patients with non-valvular atrial fibrillation.
