New Drugs 2015

NewSavaysa to reduce risk of stroke and blood clots

Savaysa (edoxaban) - Daiichi Sankyo -  The FDA has approved the anti-clotting drug Savaysa to reduce the risk of stroke and systemic embolism in patients with atrial fibrillation that is not caused by a heart valve problem.  Savaysa also has been approved to treat deep vein thrombosis and pulmonary embolism in patients who have already been treated with an anti-clotting drug administered by injection or infusion, for 5 to 10 days.  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 patients.  The trial compared 2 dose levels of Savaysa with warfarin for their effects on rates of stroke and systemic emboli.  The trial results showed the higher dose of Savaysa to be similar to warfarin for the reduction in the risk of stroke.  Warfarin is highly effective in reducing the risk of stroke in patients with atrial fibrillation, but increases the risk of bleeding.  Savaysa demonstrated significantly less major bleeding compared with warfarin.  In a clinical trial with 8,292 patients, Savaysa was studied in the treatment of DVT and PE.  The study compared the safety and efficacy of Savaysa to warfarin in treating patients with a DVT and/or PE to reduce the rate of recurrence of symptomatic venous thromboembolism (VTE) events.  In the trial, 3.2 percent of patients taking Savaysa had a symptomatic recurrent VTE compared to 3.5 percent of those taking warfarin.  The most common adverse effects were bleeding and anemia.  As with other FDA-approved anti-clotting drugs, bleeding, including life-threatening bleeding, is the most serious risk with Savaysa.  Currently 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.  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.
Approved: January 8, 2015.