For Immediate Release
January 8, 2015
The U.S. Food and Drug Administration today approved the anti-clotting drug Savaysa (edoxaban tablets) to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem.
Atrial fibrillation is one of the most common types of abnormal heart rhythm. It occurs when the heart’s two upper chambers (atria) do not contract properly, allowing blood clots to form, which can break off and travel to the brain or other parts of the body. Patients with atrial fibrillation experience an abnormal, irregular and rapid heartbeat.
Savaysa also has been approved to treat deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients who have already been treated with an anti-clotting drug administered by injection or infusion (parenterally), for five to ten days.
DVT is a blood clot that forms in a vein deep in the body, usually in the lower leg or thigh. A potentially deadly condition called PE results when a blood clot in a deep vein breaks off and travels to an artery in the lungs and blocks blood flow.
“In patients with atrial fibrillation, anti-clotting drugs lower the risk of stroke by helping to prevent blood clots from forming in the heart,” said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research. “It is important to have a variety of these types of drugs available as options for patients.”
The safety and efficacy of Savaysa in treating patients with atrial fibrillation not caused by cardiac valve disease was studied in a clinical trial of 21,105 participants. The trial compared two dose levels of Savaysa with the anti-clotting drug warfarin for their effects on rates of stroke and dangerous blood clots (systemic emboli). The trial results showed the higher dose of Savaysa to be similar to warfarin for the reduction in the risk of stroke. While warfarin is highly effective in reducing the risk of stroke in patients with atrial fibrillation, it increases the risk of bleeding. Savaysa demonstrated significantly less major bleeding compared to warfarin.
Savaysa for treatment of patients with DVT and PE was studied in 8,292 participants. The study compared the safety and efficacy of Savaysa to warfarin for treating patients with a DVT and/or PE to reduce the rate of recurrence of symptomatic venous thromboembolism (VTE) events (which includes DVT, PE, and VTE- related death). In the trial, 3.2 percent of participants taking Savaysa had a symptomatic recurrent VTE compared to 3.5 percent of those taking warfarin.
The most common side effects observed in clinical trial participants were bleeding and anemia. As with other FDA-approved anti-clotting drugs, bleeding, including life-threatening bleeding, is the most serious risk with Savaysa. There is no treatment that has been proven to reverse the anti-coagulant effect of Savaysa.
Savaysa has a Boxed Warning that provides important dosing and safety information for health care professionals about specific patient groups, including a warning that Savaysa is less effective in atrial fibrillation patients with a creatinine clearance greater than 95 milliliters per minute. A patient’s level of creatinine clearance shows how well a patient’s kidneys are working by measuring the level of the waste product creatinine in the blood or urine. This should be assessed before initiating therapy with Savaysa. Patients with creatinine clearance greater than 95 milliliters per minute have an increased risk of stroke compared to similar patients given warfarin. Savaysa should not be used in nonvalvular atrial fibrillation patients with a higher creatinine clearance. Another anticoagulant should be used instead.
As with other anticoagulants, the Boxed Warning counsels that premature discontinuation of Savaysa increases the risk of stroke and notes that spinal or epidural hematomas (collection of blood outside of a blood vessel) may occur in patients treated with Savaysa who are receiving anesthesia injected around the spine or undergoing spinal puncture.
Savaysa will be dispensed with a patient Medication Guide that provides instructions on its use and drug safety information. Health care professionals should counsel patients about the increased risk of bleeding for those taking this product.
Savaysa is made by Tokyo-based Daiichi Sankyo Co., Ltd.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.