Dose focus

How pharmacology may be driving FDA decision on Daiichi’s new anticoagulant

FDA appears to be looking for a reason to approve Daiichi Sankyo Ltd. Co.'s Savaysa edoxaban despite the fact that the Factor Xa inhibitor appears to have no advantages over the three marketed anticoagulants and may even have a unique disadvantage in patients with normal kidney function.

If approved, Savaysa would be the fourth novel oral anticoagulant approved in the indication. But although it met all of its endpoints in Phase III testing, the compound showed no major advantages compared to the marketed alternatives, according to FDA reviewers in briefing documents released ahead of the meeting.

The FDA reviewers also noted that Savaysa was less effective in preventing stroke in patients with normal renal function compared to warfarin, a shortcoming not shared by the three marketed drugs: Pradaxa dabigatran from Boehringer Ingelheim GmbH; Bayer AG's Xarelto rivaroxaban; and Eliquis apixaban from Bristol-Myers Squibb Co.

The reviewers noted that the agency would typically issue a complete response in such a situation; however, in the interest of giving doctors another option,

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