FDA Committee Recommends Daiichi Sankyo's Savaysa For Stroke
By Cyndi Root
A Food and Drug Administration (FDA) committee voted 9 to 1 to recommend Daiichi Sankyo’s Savaysa (edoxaban) for the reduction in risk of stroke and systemic embolic events (SEE) in patients with non-valvular atrial fibrillation (NVAF). Daiichi Sankyo announced the positive opinion in a press release, stating that Savaysa is a once-daily edoxaban 60 mg treatment. Edoxaban is approved in Japan for certain indications but not approved elsewhere.
Glenn Gormley, MD, PhD, Executive Chairman and President of Daiichi Sankyo, said, "We are confident that the outcomes and robustness of the ENGAGE AF-TIMI 48 study fully support the approval in the U.S. of the 60 mg dosing regimen of Savaysa for patients with NVAF, with a dose reduction to 30 mg in selected patients.”
FDA Action
The FDA’s Cardiovascular and Renal Drugs Advisory Committee met on October 30, 2014 to discuss Daiichi Sankyo’s Savaysa (edoxaban) application and made the briefing documents available to the public. The FDA committee members wrote that the submission included a full preclinical program, Chemistry, Manufacturing, and Controls data in addition to data on more than 40 clinical pharmacology studies. Authors wrote that edoxaban compared favorably with warfarin and showed a favorable reduction in hemorrhagic strokes. Compared to warfarin, edoxaban was better at reducing all kinds of bleeding except for gastrointestinal (GI) bleeding.
Edoxaban
Edoxaban is an anticoagulant that inhibits factor Xa, an important factor in the blood clotting process. Japan’s Ministry of Health, Labor, and Welfare approved edoxaban (brand name Lixiana) in 2011 and in September 2014 for the prevention of ischemic stroke and systemic embolism. Edobaxan is under review in the U.S. and the U.K. for various indications and has not been approved anywhere else except for Japan.
About Daiichi Sankyo
Recently, Daiichi Sankyo acquired Ambit Biosciences, a move which also transferred Bioscience’s quizartinib to Daiichi Sankyo. The once-daily oral treatment selectively inhibits FLT3 and slows leukemic cells from spreading. The agent is in Phase 3 clinical trials for acute myeloid leukemia (AML) patients. The company is also stretching into other Asian markets, sending a representative to Ho Chi Minh City, Vietnam to support sales promotions of existing products and to acquire license approvals for new products in Vietnam.