J&J submits Xarelto responses

Johnson & Johnson (NYSE:JNJ) submitted a response to an FDA complete response letter for an sNDA for Xarelto rivaroxaban to reduce the risk of cardiovascular events in patients with acute coronary syndrome (ACS). FDA issued the letter in June after the Cardiovascular and Renal Drugs Advisory Committee voted 6-4 against recommending approval of Xarelto in the indication. J&J said it used data from the Phase III ATLAS ACS 2 TMI 51 trial to respond to the agency's questions. The company could not be reached for details on what FDA specifically requested or how the company addressed the queries. In September 2011, J&J reported data from the trial showing Xarelto plus standard of care significantly reduced the incidence of cardiovascular death, myocardial infarction and stroke compared to standard of care alone in ACS patients.

J&J also resubmitted an sNDA to FDA for Xarelto to reduce the risk of stent thrombosis in ACS patients. J&J withdrew the sNDA in July based on its connection to the complete response letter for the other ACS indication (see BioCentury Extra, June 21). ...