FDA Approves New Blood Thinning Medication Savaysa (Edoxaban)
The FDA announced that it has approved Savaysa (edoxaban), an anti-clotting drug manufactured by Tokyo-based Daiichi Sankyo and used 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 problems. Savaysa has also been approved by the FDA 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.
Forbes reports that last year the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 9-1 in favor of approval for the AF indication. However, the panel discussed concerns regarding a troubling subgroup analysis in the otherwise positive Engage AF-TIMI 48 trial, which suggested that the benefit associated with edoxaban occurred only in those patients with impaired renal function, rather than those patients with normal renal function. Both the FDA reviewers and panel members came to the conclusion that this aspect could have important clinical implications for patients. As a result, the FDA will require that the product labeling for Savaysa contain a Black Box Warning that the drug is less effective in atrial fibrillation patients with a creatinine clearance (CrCl) greater than 95 ml/min, that physicians should measure CrCl prior to initiating Savaysa, and that patients with CrCl levels over 95 ml/min should receive a different anticoagulant.
Sanjay Kaul, a member of the FDA’s Cardiovascular and Renal Drugs Advisory Committee, spoke about the limited commercial prospects of the drug. Kaul said, “It appears that the restriction of use in patients with creatinine clearance <95 ml/min applies only for NVAF indication. The creatinine clearance cut off used for impaired renal function during the FDA panel meeting was <80 ml/min; based on this criterion, nearly one-third had normal renal function representing a large subgroup in whom treatment with edoxaban would yield unfavorable results compared with warfarin. The final FDA approval appears to have relaxed this criterion to CrCl <95 ml/min, thereby expanding the pool of patients eligible for edoxaban. Regardless, there is no unique advantage this drug offers relative to existing therapies. As such, clinical acceptability and marketability will pose a major challenge for this drug.”
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