title: Apixaban: first global approval.
abstract: Apixaban (Eliquis™), an oral direct factor Xa inhibitor, is being developed by Bristol-Myers Squibb and Pfizer as a therapy for the prevention and/or treatment of thrombotic disorders. Apixaban has been approved in the EU for the prevention of venous thromboembolism (VTE) after hip or knee replacement. A rolling submission for approval of apixaban for the prevention of stroke in patients with atrial fibrillation has also been initiated in the US. Worldwide phase III development of apixaban is underway for the prevention and treatment of VTE, and prevention of stroke in patients with atrial fibrillation. Development for acute coronary syndromes has been stopped following the discontinuation of the phase III APPRAISE-II trial. This article summarizes the milestones in the development of apixaban leading to this first approval for the prevention of VTE after hip or knee replacement.
authors: RD Insight, Wolters Kluwer Pharma Solutions, Auckland, New Zealand.
authors: Julia
authors: J
authors: Watson
authors: Glen
authors: G
authors: Whiteside
authors: Caroline
authors: C
authors: Perry
mesh_terms: D002986:Clinical Trials as Topic; D017277:Drug Approval; D065427:Factor Xa Inhibitors; D005343:Fibrinolytic Agents / Q000737:chemistry / Q000627:therapeutic use*; D006801:Humans; D011720:Pyrazoles / Q000737:chemistry / Q000627:therapeutic use*; D011728:Pyridones / Q000737:chemistry / Q000627:therapeutic use*; D020521:Stroke / Q000517:prevention & control*; D054556:Venous Thromboembolism / Q000517:prevention & control*
chemical_list: D065427:Factor Xa Inhibitors; D005343:Fibrinolytic Agents; D011720:Pyrazoles; D011728:Pyridones; C522181:apixaban