PRINCETON, NJ and NEW YORK, NY — The US Food and Drug Administration has accepted the supplemental new drug application for apixaban (Eliquis, Bristol-Myers Squibb/Pfizer), extending its indication for use to prophylaxis of deep vein thrombosis (DVT) and pulmonary embolism (PE) in adults who have undergone hip- or knee-replacement surgery.
Full prescribing information for the drug warns about the increased risk of stroke in patients with nonvalvular atrial fibrillation who discontinue the drug without some other form of anticoagulation, "and for the increased risk of epidural or spinal hematoma, which may cause long-term or permanent paralysis, in patients using Eliquis and undergoing spinal epidural anesthesia or spinal puncture."
The companies have also submitted a supplemental new drug application for the treatment of DVT and PE and to reduce the risk of DVT and PE recurrence; the FDA is expected to make a decision on that indication in late August.
Apixaban joins rivaroxaban (Xarelto, Bayer Pharma/Janssen Pharmaceuticals), another novel oral anticoagulant approved for DVT/PE prophylaxis in the setting of hip and knee surgery. Rivaroxaban won approval for this indication in 2011.
According to a press statement from the companies, over 700 000 total knee replacement surgeries and more than 332 000 hip replacement surgeries are performed every year in the US, necessitating anticoagulation.
Cite this: Apixaban (Eliquis) Approved for DVT/PE Prophylaxis Post-Hip or Knee Replacement - Medscape - Mar 14, 2014.