FDA requests more data on Xarelto

The FDA has issued a second complete response letter to Janssen Pharmaceuticals regarding a supplemental new drug application for rivaroxaban for the reduction of risk for CV events in patients with ACS.

In February, Janssen Pharmaceuticals received a priority review designation from the FDA regarding the supplemental new drug application for the ACS indication and, in June, the company received a complete response letter from the FDA. In September, the company submitted data on patients who had withdrawn from the ATLAC ACS 2 TIMI 51 trial as part of the complete response, according to a press release.

“To compile these data, the company undertook a global effort and was able to confirm the vital status of information for 843, or 63%, of the 1,338 trial participants who previously had unknown vital status. The mortality benefit observed during the treatment phase of the study was maintained. These new events were distributed equally between the three treatment groups (2.5 mg, 5 mg and placebo) of patients who were alive (806) and those who had died (37). After these efforts, follow-up data [were] not available on only 2.4% of patients,” the statement reads.

The supplemental new drug application includes results from the phase 3 ATLAS ACS 2-TIMI 51 trial involving 15,526 patients and phase 2 ATLAS ACS 2-TIMI 46 trial involving 3,491 patients.

Currently, rivaroxaban (Xarelto) is FDA approved to reduce the risk for stroke and systemic embolism in patients with nonvalvular atrial fibrillation; to reduce the risk for deep vein thrombosis or pulmonary embolism after hip or knee replacement surgery; and for the treatment of deep vein thrombosis or pulmonary embolism and reduction of risk for recurrence after initial treatment.