FDA: Limit use of anticoagulant edoxaban

FDA advisors have recommended approval of a 60-mg dose of edoxaban (Daiichi Sankyo), a once-daily anticoagulant that inhibits Factor Xa, for some atrial fibrillation patients, but suggested limiting its use to those with abnormal kidney function.

According to the FDA advisors, the 60-mg dose of edoxaban was markedly superior to warfarin, a widely used anticoagulant, in mildly renally impaired patients, it was almost significantly worse in patients with normal renal function.

“The positive FDA review is good news for Daiichi as it awaits formal approval for edoxaban,” according to John Santilli of Access Market Intelligence, which provides market intelligence to the pharmaceutical and healthcare industries.

“Edoxaban matched warfarin at preventing stroke and blood clots and exceeded it for safety, paving the way for the company to compete in the soon to be $10-plus billion market for warfarin-alternative drugs,” Santilli said.

The not-so-positive news for Daiichi is they are going to face some well-established competitors in the market including: Boehringer-Ingelheim’s growing Pradaxa [dabigatran etexilate]; Bayer and Johnson & Johnson’s Xarelto [rivaroxaban]; and Pfizer’s and Bristol-Myers Squibb’s Eliquis [apixaban], without a difference-making product,” he added.

“Edoxaban is another oral anticoagulant that works in a similar way to rivaroxaban,” according to FormularyWatch advisor James M. Wooten, PharmD, associate professor, department of medicine, section of clinical pharmacology, University of Missouri-Kansas City.

“I believe FDA is basically saying that this new drug offers no advantages to current therapy but because it primarily undergoes hepatic metabolism it is probably safer to use in patients with renal dysfunction,” Dr Wooten said. 

“The problem with all of these new oral anticoagulants is that in situations of overdose and/or bleeding there is still no definitive way to reverse the drug’s process and this is why these drugs are very dangerous unless closely monitored,” he added.

The proposed brand name for edoxaban in the United States is Savaysa.