Corporate Banner
Satellite Banner
Biomolecular Screening
Scientific Community
Become a Member | Sign in
Home>News>This Article

U.S. FDA Approves DVT Drug Eliquis®

Published: Monday, March 17, 2014
Last Updated: Tuesday, March 18, 2014
Bookmark and Share
The approval gives U.S. orthopedic surgeons a new option for DVT prophylaxis in both hip and knee replacement surgery.

Bristol-Myers Squibb Company and Pfizer Inc. today announced that the U.S. Food and Drug Administration (FDA) approved a Supplemental New Drug Application (sNDA) for Eliquis (apixaban) for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery.

“Today’s FDA approval of Eliquis for DVT prophylaxis in patients who have undergone hip or knee replacement is a significant milestone for this important medicine, which is also approved to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation,” said Brian Daniels, M.D., senior vice president, global development and medical affairs, Bristol-Myers Squibb. “This approval reflects the continued commitment of the alliance to deliver new treatment options for patients and physicians.”

“As the number of hip and knee replacement surgeries performed in the U.S. continues to increase, the risk of DVT following these surgeries remains a concern for physicians,” said Steven J. Romano, M.D., senior vice president and Medicines Development Group Head, Global Innovative Pharmaceuticals Business, Pfizer Inc. “Eliquis provides patients and physicians with a new treatment option that offers twice daily oral dosing and no routine coagulation testing, and is broadly accessible through hospitals and managed health care formularies.”

The full Prescribing Information for Eliquis includes Boxed Warnings for the increased risk of stroke in patients with nonvalvular atrial fibrillation who discontinue Eliquis without adequate continuous 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. Please see complete Boxed Warnings and additional Important Safety Information in this press release.

DVT, a blood clot that forms in a large vein, usually in the lower leg, thigh, or pelvis, can lead to PE when a portion or all of a blood clot breaks off and travels to the lungs, blocking one or more blood vessels. PE can lead to sudden death.

Based on recent data, each year in the U.S. an estimated 719,000 total knee replacement surgeries and 332,000 hip replacement surgeries are performed. Patients undergoing hip or knee replacement surgery without thromboprophylaxis are at risk for developing DVT and PE. Guidelines recommend the use of anticoagulants for the prophylaxis of DVT and PE for most patients undergoing orthopedic surgery.

“DVT, which may lead to PE, is a serious medical condition,” said Richard J. Friedman, M.D., FRCSC, Professor of Orthopaedic Surgery, Medical University of South Carolina. “The FDA approval of Eliquis gives U.S. orthopedic surgeons a new option for DVT prophylaxis in both hip and knee replacement surgery.”

This sNDA approval for Eliquis is supported by three clinical trials (the ADVANCE clinical trial program). The ADVANCE trials randomized more than 11,000 patients, with 5,770 receiving Eliquis and 5,755 receiving enoxaparin, to assess the safety and efficacy of Eliquis.
In December 2013, the FDA accepted for review another sNDA for Eliquis for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE.

Further Information
Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,800+ scientific posters on ePosters
  • More than 4,000+ scientific videos on LabTube
  • 35 community eNewsletters

Sign In

Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

BMS Partners with Medical University
The Medical University of South Carolina and Bristol-Myers Squibb Company have announced that they have entered into a collaboration focused on fibrotic diseases, including scleroderma, renal fibrosis and idiopathic pulmonary fibrosis.
Thursday, July 16, 2015
Bristol-Myers Squibb and Calibr Collaborate
Collaboration and license agreement focused on new treatment approaches for fibrotic diseases.
Thursday, January 08, 2015
FDA Grants Breakthrough Designation for Multiple Myeloma Drug
Bristol-Myers Squibb and AbbVie received the designation for Elotuzumab, an investigational humanized monoclonal antibody for multiple myeloma.
Tuesday, May 20, 2014
Scientific News
High Throughput Mass Spectrometry-Based Screening Assay Trends
Dr John Comley provides an insight into HT MS-based screening with a focus on future user requirements and preferences.
Potential Treatment for Life-Threatening Viral Infections Revealed
The findings point to new therapies for Dengue, West Nile and Ebola.
World’s First Therapeutic Venom Database
Open-source library describes nearly 43,000 effects on the human body.
Measuring microRNAs in Blood to Speed Cancer Detection
A simple, ultrasensitive microRNA sensor holds promise for the design of new diagnostic strategies and, potentially, for the prognosis and treatment of pancreatic and other cancers.
Potential Persistent Tuberculosis Treatment
Researchers have discovered several first-in-class compounds that target hidden TB infections by attacking a critical process the bacteria use to survive in the hostile environment of the lungs.
Metabolic Profiles Distinguish Early Stage Ovarian Cancer with Unprecedented Accuracy
Studying blood serum compounds of different molecular weights has led scientists to a set of biomarkers that may enable development of a highly accurate screening test for early-stage ovarian cancer.
The Do’s and Don’ts of SPR Experiments
Surface Plasmon Resonance (SPR) is a technique that is becoming more widely used, particularly by anyone who wants to obtain accurate on (association) and off (dissociation) rates for biomolecular binding.
Long-Sought Protein Sensor for the ‘Sixth Sense’ Discovered
In a study led by scientists from The Scripps Research Institute (TSRI)the sensor protein for propioception has been identified.
New Anti-Malarial Drug Screening Model
University of South Florida researchers demonstrate novel chemogenomic profiling to identify drug targets for the most lethal strain of malaria.
Shedding Light on “Dark” Cellular Receptors
UNC and UCSF labs create a new research tool to find homes for two orphan cell-surface receptors, a crucial step toward finding better therapeutics and causes of drug side effects.

Skyscraper Banner
Go to LabTube
Go to eposters
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,800+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,000+ scientific videos