FDA actions

FDA actions

The FDA has issued opinions on two oral novel anticoagulants. The agency turned down Janssen's application for approval of rivaroxaban (Xarelto) for the treatment of acute coronary syndrome, at least for now. The FDA did not release the reasons for the decision, but speculation is they want more information from the ATLAS-ACS trial. Rivaroxaban was approved last year for prevention of venous thromboembolism after hip or knee replacement surgery, and also for stroke prevention in patients with non-valvular atrial fibrillation (AF). The FDA also delayed the approval of apixaban (which would represent the third novel oral anticoagulant along with dabigatran and rivaroxaban) for the prevention of stroke and systemic embolism in patients with non-valvular AF. It had been widely speculated that the drug would be approved this spring, especially given that the FDA had granted a priority review for apixaban last November. The delay is similarly due to the need for additional information from the ARISTOTLE trial. Once approved apixaban will be marketed by Bristol-Myers Squibb as Eliquis.