Japanese drug maker Daiichi Sankyo Co’s blood thinner has been approved by a U.S. Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee by a 9-1 vote. Their blood thinner, called edoxaban, can now be used on patients with nonvalvular atrial fibrillation. That is a type of arrhythmia (rapid, irregular heartbeat) which can cause a stroke. Edoxaban (Savaysa) is a once a day anticoagulant which checks the Factor Xa, a protein which can affect the process of blood clotting significantly.
Edoxaban will now have to compete with three other drugs (Xarelto, sold by Bayer AG and Johnson & Johnson; Eliquis, sold by Bristol-Myers Squibb Co and Pfizer Inc, and Pradaxa, made by privately held Boehringer Ingelheim) which are already in queue as a replacement to a treatment which has been followed for several decades now.
According to late-stage trial data submitted by Daiichi, the drug is as effective – and safer than – warfarin, an anticoagulant that has been on the market for more than half a century. Though warfarin has been around for a long time with very good results, there are some problems associated with its usage. Users have to get their blood level monitored and follow certain dietary restrictions apart from dose adjustments from time to time.
“We are confident that the outcomes and robustness of the ENGAGE AF-TIMI 48 study fully support the approval in the U.S. of the 60 mg dosing regimen of Savaysa for patients with NVAF, with a dose reduction to 30 mg in selected patients,” said Glenn Gormley, MD, PhD, senior executive officer and global head of research and development for Daiichi Sankyo Co Ltd, and executive chairman and president for Daiichi Sankyo, Inc. “We will continue to work with the FDA as it completes its review of our new drug application for Savaysa for the prevention of stroke and SEE in patients with atrial fibrillation.”
It is to be noted that though FDA seeks advice from its regulatory bodies from time to time, it is not bound to act on their suggestions or recommendations, though it usually does heed to them. So, though the panel’s overwhelming vote in favor of Daiichi Sankyo should be music for the Japanese drug maker’s ears for now, it is not yet certain whether the FDA will give it the green signal.