The FDA has approved Daiichi Sankyo’s SAVAYSA™ - an oral anticoagulant

WASHINGTON - Jan. 9, 2015 - PRLog -- SAVAYSA™ (edoxaban) tablets, an oral once-daily selective factor Xa-inhibitor have been approved by the U.S. Food and Drug Administration (FDA) to reduce the risk of stroke and systemic embolism (SE) ) in patients with non-valvular atrial fibrillation (NVAF).

According to the ENGAGE AF-TIMI 48 trial conducted, NVAF patients treated with SAVAYSA had significantly less major bleeding and lower rates of intracranial hemorrhage compared to warfarin. In the Hokusai-VTE study, SAVAYSA was assessed for the recurrence of symptomatic venous thromboembolism and was revealed to be non –inferior to warfarin. Patients with VTE who were treated with SAVAYSA also had a lower bleeding rate of 19% compared to warfarin.

"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 Chief Executive Officer, Daiichi Sankyo Company, Limited. "We look forward to making SAVAYSA available to patients in the U.S. with NVAF and venous thromboembolism, two serious conditions that are expected to double in prevalence by mid-century."

"SAVAYSA is an important new anticoagulant in the U.S. 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 Company, Limited and Executive Chairman and President, Daiichi Sankyo, Inc. "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."

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