FDA Advisory Committee Supports New Anticoagulant Drug Savaysa® (Edoxaban)
Forbes reports that the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 9-1 in favor of approval for Savaysa® (Edoxaban), an anticoagulant manufactured by Daiichi Sankyo. If approved by the FDA, this drug will become the fourth novel oral anticoagulant (NOAC) to receive FDA approval alongside Pradaxa, Xarelto, and Eliquis.
Although the panel clearly supported approval of the drug, the panel differed in regard to labeling. In particular, the advisory committee discussed the possibility of future trials that would adjust the dose based on renal function and even the possibility of limiting the use of the drug to only those patients with impaired renal function. This discussion was based on the fact that a subgroup analysis from the primary clinical trial at issue involving edoxaban, ENGAGE AF, demonstrated that all of the benefits of edoxaban occurred in the large group of patients with impaired renal function.
FDA Advisory Committee panel member Sanjay Kaul provided the following statement to Forbes: “The committee struggled with the core issue for discussion around the subgroup of patients with normal renal function where the benefit-risk balance was not optimal. Decisions based on subgroup analysis can be potentially treacherous at times, however, there were elements in the evidence base that made the results relatively credible. Given the size of the subset, the FDA was concerned about the potential public health impact of approving the drug in patients with normal renal function. Majority of the panel agreed with their assessment. There is no unique advantage that this drug offers that is not seen with approved existing therapies. Approvability is less of an issue relative to clinical acceptability and marketability being the fourth kid on the block.”
The FDA has not made a final decision as of yet regarding the approval of Savaysa® (edoxaban). The conclusions and results from this Advisory Committee meeting at issue have only been taken under advisement by the FDA. As explained by the FDA, “[a]dvisory committees provide FDA with independent advice from outside experts on issues… [a]lthough the committees provide advice to the agency, FDA makes the final decisions.”
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