Dr. Sanjay Kaul, professor of medicine at the University of California, Los Angeles, said that considering currently available options, “I did not find any unique clinical scenario where this drug would offer an advantage that’s not already there ... but physicians like choices.” He supported approval for patients with mild and moderate renal impairment, but added that the company should be given an opportunity to clarify the benefit-risk ratio with regard to a higher dose in patients with normal renal function.
The panelist who voted against approval, Dr. Stuart Rich, professor of medicine at the University of Chicago, said he voted no because the only choice would be to support approval for patients with renal dysfunction, based on the evidence. But he questioned what clinicians would do if a patient’s renal function normalized, which could create problems, and cited the availability of other treatment options.
The FDA, which has never approved a dose higher than the doses studied in clinical trials of a drug, usually follows the recommendations of its advisory panels. Panelists had no conflicts of interest related to the topic of the meeting.
If approved, edoxaban would be the fourth novel oral anticoagulant (NOAC) to be cleared by the FDA, after dabigatran (Pradaxa), rivaroxaban (Xarelto), and apixaban (Eliquis). Edoxaban was approved in Japan for this indication in September, and is under review for this indication in Europe. Daiichi Sankyo plans to market edoxaban as Savaysa in the United States. The drug is also being reviewed for a venous thromboembolism indication (approved in Japan) in the United States and Europe.