Janssen responds to FDA's Xarelto CRL; resubmits sNDA

Johnson & Johnson (NYSE: JNJ) subsidiary Janssen Research & Development, German drug major Bayer’s (BAYN: DE) partner for Xarelto (rivaroxaban) in the USA, last Friday submitted the Complete Response to the US Food and Drug Administration for the use of 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 its letter issued to Janssen in June. Prior to that, the FDA's Cardiovascular and Renal Drugs Advisory Committee narrowly voted (six to four with one abstention) against recommending approval of rivaroxaban in this indication (The Pharma Letter May 24).

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