Janssen submits complete response to FDA on rivaroxaban


Janssen has announced that it has submitted the complete response to the US Food and Drug Administration (FDA) for the use of rivaroxaban (Xarelto) to reduce the risk of secondary cardiovascular events in patients with acute coronary syndrome (ACS). The response includes specific information requested by the FDA in their letter issued to Janssen on 21 June 2012.

Janssen also has resubmitted the supplemental New Drug Application (sNDA) for rivaroxabanto reduce the risk of stent thrombosis in patients with ACS, which the company withdrew on 9 July 2012 based on its connection to the above mentioned sNDA for rivaroxaban. Data from the ATLAS ACS 2 TIMI 51 trial support both sNDAs.

“We are confident in the results of the ATLAS ACS 2 TIMI 51 trial and have relied on the data from that study to develop our comprehensive responses to questions raised by the FDA in their review of our application,” said Paul Burton, vice president at Janssen R&D. “We look forward to working with the agency to make Xarelto available to patients who experience a heart attack and need treatment to reduce the risk of another heart attack, a blocked coronary stent or death.”

Rivaroxaban is approved for three clinical uses in the USA: to reduce the risk of blood clots in the legs and lungs of people who have just had knee replacement surgery, to reduce this risk in people who have just had hip replacement surgery, and to reduce the risk of both haemorrhagic and thrombotic strokes as well as other blood clots in people with atrial fibrillation not caused by a heart valve problem.