DALLAS Nov 19 A new blood clot and stroke preventer from Daiichi Sankyo proved as effective and safer than widely used warfarin in a large, late stage trial of patients with atrial fibrillation, paving the way for it to compete with other new warfarin alternatives on the market.
The drug, edoxaban, met the main efficacy and safety goals of the study by demonstrating "non-inferiority" to warfarin in preventing strokes and blood clots and led to significantly less major bleeding - the greatest danger of blood thinning medicines.
The trial, dubbed Engage AF, tested two doses of edoxaban against warfarin in 21,105 patients with atrial fibrillation - a dangerously irregular heartbeat - at moderate to high risk of stroke. The trial followed patients on average for nearly three years, making it the largest and longest study to date of any of the new generation of blood thinners.
The data was presented on Tuesday at the American Heart Association scientific meeting in Dallas.
Atrial fibrillation is seen as the most important use for these drugs. People with this most common type of arrhythmia, which affects nearly three million Americans, are five times more likely to suffer a stroke.
Edoxaban, a once a day pill, is already sold in Japan under the brand name Lixiana and Daiichi said it plans to file its application seeking U.S approval in the first quarter of 2014.
"Personally I think it will be used. We know this drug is safer than warfarin," said the study's lead investigator, Dr. Robert Giugliano, cardiologist at Brigham and Women's Hospital in Boston.
But it will enter a market that already has three other new medicines vying to displace cheap, decades-old warfarin.
It aims to compete with Xarelto, sold by Bayer AG and Johnson & Johnson, and Eliquis sold by Bristol-Myers Squibb Co and Pfizer Inc, which belong to the same class of drugs as edoxaban, as well as a similar medicine from Boehringer Ingelheim called Pradaxa.
Industry analysts believe the new blood thinners could eventually generate sales of more than $10 billion a year.
But without any head-to-head trials that can definitively show one of the novel anticoagulants is better than another, this will likely come down to a marketing war among pharmaceutical heavyweights.
"If you look the four new drugs, they're more similar than different," said Dr. Mark Link, a professor at Tufts University Medical Center in Boston, who was not involved in the trial. "All these drugs are safer than warfarin."