An FDA advisory panel meets today to discuss the safety and efficacy of yet another novel oral anticoagulant. The standards for approval may be shifting, though.
The Cardiovascular and Renal Drugs Advisory Committee will review a new drug application for Daiichi Sankyo’s edoxaban (Lixiana). Like two approved drugs before it, edoxaban is a Factor Xa inhibitor that has been tested against the warhorse warfarin to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
The other two approved anticoagulants are rivaroxaban (Xarelto, Janssen Pharmaceuticals/Bayer HealthCare) and apixaban (Eliquis, Bristol-Myers Squibb/Pfizer). Add to the options now facing physicians and their patients dabigatran (Pradaxa, Boehringer Ingelheim), a direct thrombin inhibitor.
The panelists will sift through clinical trial data for both low-dose and high-dose edoxaban vs. warfarin. Both met the noninferiority mark but preparatory material from the FDA described the high dose as “nearly superior” and the low dose as “nearly significantly worse.”
In its draft questions, the FDA proposes that “given the availability of several NOACs [novel oral anticoagulants] that work well in people with normal renal function, it might be concluded that there is more work to do before edoxaban is approved.”
The vote comes at a time of what one analysis calls heightened scrutiny by regulators. A.T. Kearney, a management consulting company, identified this and four other changes making headwinds for the medical device industry. Those same forces likely apply to drugs, too.
The analysts concluded that the cardiovascular segment would be smacked by all five market disruptions, with regulatory scrutiny and the need to serve lower socioeconomic patient groups listed as more critical than the other three factors. An increasing emphasis on value demands proof of superiority, not just noninferiority, they claim.
It will be interesting to see what kind of reception this fourth novel oral anticoagulant receives and whether noninferiority cuts it this time around. Whatever the final vote, the FDA can ignore the panel’s recommendations, although it rarely does. This is one to watch.
Editor, Cardiovascular Business