Daiichi Sankyo Co.’s experimental blood thinner edoxaban was found to be as effective and safer than standard treatment warfarin in a study that clears the way for the Japanese company to compete with drugmakers including Pfizer Inc., Johnson & Johnson and Bristol-Myers Squibb Co.
The 8,240-patient study found that a once-daily edoxaban pill given after initial heparin therapy was equal to the generic medicine warfarin at preventing new blood clots in patients who have had blockages in a vein or lung. Patients who took edoxaban had significantly less bleeding, a feared side effect of blood thinners, than patients on warfarin.
The results of the study allow Daiichi Sankyo to join the race to replace warfarin, a more than half-century-old therapy that requires close monitoring to avoid side effects such as severe bleeding that can be life-threatening. Edoxaban is the third in a group of would-be warfarin heirs called Factor Xa inhibitors, following J&J and Bayer AG’s Xarelto and Pfizer and Bristol-Myers’s Eliquis.
“Doctors will probably just see it as another Factor Xa,” Tim Race, a London-based analyst for Deutsche Bank AG, said in an e-mail. “They will need to market it hard to be successful.”
Daiichi Sankyo jumped the most in a month, gaining 3 percent to 1,741 yen on the Tokyo Stock Exchange at 9:37 a.m. local time. The Topix index advanced 0.7 percent.
Daiichi Sankyo is seeking to offset a probable drop in sales when its best-selling Benicar hypertension drug loses patent protection in 2016. Possible replacements include edoxaban and another anti-clotting treatment called Effient, which was approved in the U.S. in 2009. Benicar generated 258.8 billion yen ($2.6 billion) of sales in the year through March, accounting for 26 percent of Daiichi Sankyo’s revenue.
The Japanese company will submit edoxaban for regulatory approval in the U.S., Europe and more widely in Japan by the first quarter of next year, said Glenn Gormley, head of research and development. The drug has been on the market for post-surgery clot prevention in Japan since 2011.
Patients in the four-year-long study, dubbed Hokusai-VTE, took edoxaban or warfarin for as long as 12 months after being diagnosed with a blood-clotting condition called venous thromboembolism. The drugs were equally effective across a broad range of patients, the goal of the study. A subgroup of patients with severe blockages in the arteries of the lungs did better on edoxaban than on warfarin, the researchers said.
Meanwhile, 8.5 percent of the patients who took edoxaban experienced bleeding as a side effect, compared with 10.3 percent of the warfarin group.
“This agent gets the job done with less risk,” said Sidney Smith, director of the center for cardiovascular science and medicine at the University of North Carolina School of Medicine, who wasn’t involved with the study or any of the drugmakers. “It’ll come down to how various health care systems and doctors view this.”
In venous thromboembolism, clots form in veins deep in the body, often in the legs. The clots can then break off and travel into the lungs, causing a potentially deadly pulmonary embolism.
Between 300,000 and 900,000 people in the U.S. are affected by VTE each year, according to the Centers for Disease Control and Prevention in Atlanta. Almost half of the conditions occur either during or soon after discharge from a hospital stay or surgery and an estimated 60,000 to 100,000 Americans die of the illness each year.
A look at past examples such as the development of ACE inhibitors to treat high blood pressure suggests there’s scope for several different drugs to treat those patients, said Keith Fox, professor of cardiology at the Center for Cardiovascular Science at the University of Edinburgh.
Instead of one of the new drugs emerging as best in class, doctors may pick a treatment -- either one of the new medicines or warfarin -- based on each patient’s characteristics, said Mariell Jessup, president of the American Heart Association and medical director of the Penn Heart and Vascular Center.
“It’ll take some time for people to understand the advantages and disadvantages,” Jessup said. “It’s nice to have more than one, because there probably are some unique situations” where one drug will work better than another.
A way to reverse the effects of the new anti-clotting drugs -- which is possible with older warfarin -- would be a big advantage, Jessup said. A lower price for the new drug class would also be helpful, she said.
Daiichi’s Gormley declined to comment on pricing.
The company is also testing edoxaban in patients with a heart rhythm disorder called atrial fibrillation, to prevent blood clots from forming in the heart. If it’s approved in both groups of patients, sales of edoxaban are expected to reach 40 billion yen by the year ending March 2018, according to SMBC Nikko Securities Inc.
“Edoxaban will face intense competition when it reaches the market,” Yasuhiro Nakazawa, a health-care analyst at SMBC Nikko in Tokyo, said in a telephone interview before the study results were published. “Patients and doctors don’t seem to switch brands once they are on medication, so it’ll be a slow start for Daiichi Sankyo.”
Edoxaban will probably also compete with Boehringer Ingelheim GmbH’s Pradaxa, another warfarin-replacing pill that works in a slightly different way. Pradaxa is approved in the U.S. for atrial fibrillation patients, and Boehringer last month sought approval for venous thromboembolism as well.