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2014: A big year for new oral anticoagulants
This promises to be quite a year with regard to new oral anticoagulants.
FDA decisions on the approval of dabigatran (Pradaxa, Boehringer Ingelheim) and apixaban (Eliquis, Bristol-Myers Squibb) are pending.
Also, on Jan. 8, Daiichi Sankyo applied for FDA approval for edoxaban (Savaysa) for two indications: (a) the treatment of deep vein thrombosis or pulmonary embolism, as well as the prevention of recurrence of symptomatic venous thromboembolism; and (b) the reduction of risk for stroke and systemic embolic events in patients with non-valvular atrial fibrillation.
Stephan Moll
This application is based on the two large phase 3 edoxaban trials — one in VTE and one in atrial fibrillation — both published in 2013 in The New England Journal of Medicine.
The table summarizes the FDA approval and application status of the four big new oral anticoagulants. It suggests 2014 appears to be an exciting year with potentially more options available for the treatment of VTE and atrial fibrillation.
Table. FDA approval status of new oral anticoagulants.
Source: Moll S.
References:
The Hokusai-VTE Investigators. N Engl J Med. 2013;369:1406-1415.
Giugliano RP. N Engl J Med. 2013;369:2093-104.
For more information:
Stephan Moll, MD, is an associate professor in the Department of Medicine and Division of Hematology-Oncology at the University of North Carolina School of Medicine in Chapel Hill, N.C. He can be reached at the UNC Hemophilia and Thrombosis Center, 170 Manning Drive, 3rd Floor Physicians Office Building, Campus Box 7035, Chapel Hill, NC 27599-7016; email: smoll@med.unc.edu.
Disclosure: Moll has been a consultant for Boehringer-Ingelheim, CSL Behring, Daiichi and Janssen.