FDA approves Savaysa tabs from Daiichi Sankyo
TOKYO, Japan and PARSIPPANY, N.J. — Daiichi Sankyo Co., Limited on Friday announced that the Food and Drug Administration has approved Savaysa (edoxaban) tablets, an oral, once-daily selective factor Xa-inhibitor that reduces the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.
The drug also was approved to treat deep vein thrombosis and pulmonary embolism following five to 10 days of intial therapy with a parenteral anticoagulant, the company stated.
“The approval of Savaysa demonstrates our commitment to providing new treatment options for cardiovascular diseases with significant unmet needs and reinforces our leadership in factor Xa-inhibition research, which began more than 30 years ago,” said Joji Nakayama, representative director, president and CEO, Daiichi Sankyo Co., Limited. “We look forward to making Savaysa available to patients in the United States with NVAF and venous thromboembolism, two serious conditions that are expected to double in prevalence by mid-century.”
The approval for these indications are based on data gathered from the Engage AF-TIMI 48 and Hokusai-VTE studies. According to the company, the most common side effects observed in clinical trial participants were bleeding and anemia.
“Savaysa is an important new anticoagulant in the United States and in the Engage AF-TIMI 48 trial, Savaysa has been shown to reduce the risk of stroke and SE with significantly less major bleeding for patients with NVAF, and in the Hokusai-VTE trial, to treat DVT and PE with significantly less clinically relevant bleeding versus warfarin, the most commonly prescribed anticoagulant,” said Glenn Gormley, MD, PhD, senior executive officer and global head of R&D, Daiichi Sankyo Co., Limited and executive chairman and president, Daiichi Sankyo. “In addition, Savaysa offers the convenience of once-daily dosing, no need for routine blood monitoring and the flexibility to be taken with or without a meal.”