The FDA has issued a second complete response letter on a supplemental New Drug Application (sNDA) for rivaroxaban for the reduction of the risk of cardiovascular events in patients with acute coronary syndrome (ACS).
In early 2012, Janssen Research & Development received a priority review designation from the FDA for rivaroxaban (Xarelto) to reduce the risk of secondary cardiovascular events in patients with ACS. But in May, the FDA’s Cardiovascular and Renal Drugs Advisory Committee recommended against approval after a debate about the results of the ATLAS ACS 2 TIMI trial that mainly focused on missing data and bleeding risks.
The FDA issued its first sNDA in June and in September, Janssen submitted its reply, including data from the ATLAS ACS 2 TIMI 51 trial.
Raritan, N.J.-based Janssen said it is evaluating the second letter and will respond to the FDA’s questions.