The U.S. Food and Drug Administration (FDA) approved Eliquis use for the treatment and risk reduction of recurring DVT and PE conditions, drug maker Bristol-Myers Squibb said in a statement on Aug. 21.
Douglas Manion, M.D., Specialty Development head at Bristol-Myers Squibb, says they are pleased with the approval of the drug as effective treatment alternative for DVT and PE.
“Eliquis offers oral dosing, no routine coagulation testing, and does not require the use of a parenteral anticoagulant or bridging during initiation,” says Manion in a statement.
Eliquis, or chemically termed as apixaban, is an oral selective inhibitor of the key blood-clotting protein called Factor Xa. By inhibiting said protein, Eliquis minimizes blood clot formation and thrombin generation.
Meanwhile, DVT is a condition that involves a blood clot in the vein, normally in the thigh, lower leg or pelvis, which blocks the blood flow partially or totally. It brings about various symptoms such as redness, swelling and pain. It can advance to PE, eventually carrying a risk of sudden death.
PE is also a blood clot but that which blocks one or more vessels in one’s lungs. When combined, DVT and PE are referred to as VTE.
“Once a VTE has occurred, approximately 33 percent of patients are at risk of a recurrence within 10 years,” says Steve Romano, SVP and Medicines Development Group head for Global Innovative Pharmaceuticals of Pfizer Inc.
Yearly, an estimate of 900,000 Americans suffer from PE and DVT.
Romano says the alliance of Pfizer and Bristol is dedicated to providing essential treatment alternatives to physicians and patients. The two drug companies agreed in 2007 to a worldwide collaboration in the development and commercialization of apixaban.
Eliquis has been approved for numerous indications in the U.S. as based on its efficiency and safety data, plus the results from seven Phase 3 clinical trials. Said approval is based on information from global studies called AMPLIFY and AMPLIFY-EXT.
AMPLIFY study is a random, double-blind trial designed to show the safety and effectiveness of Eliquis for treatment of PE and DVT, including patients with confirmed symptomatic PE or DVT.
Eliquis, however, increases bleeding risk and can bring about serious and potentially fatal bleeding, which is why the full prescribing information for the drug includes additional warnings. One warning states an added risk of thrombotic events in patients who discontinue prematurely the treatment. The other warning says an added risk of spinal or epidural hematoma that may lead to long-term to permanent paralysis for patients taking the drug and undertaking spinal puncture or spinal epidural anesthesia.
