[This oral FXa inhibitor has had a very much lower profile than Xarelto and Apixaban, which may be attributable to the fact that investors pay more attention to US-based Big Pharma than to Japanese companies. The phase-2 trial in hip surgery was a success, and a phase-3 trial in AF is expected to begin before year-end. One oddity of the phase-2 trial is that Fragmin (dalteparin) rather than Lovenox was used as the comparator drug.]
MUNICH, Germany, Sept. 2 /PRNewswire-FirstCall/ -- Data presented today at the Annual Congress of the European Society of Cardiology showed that the investigational oral Factor Xa inhibitor DU-176b reduced the incidence of venous thromboembolism (VTE) compared with dalteparin among patients undergoing elective unilateral hip replacement surgery. There was a statistically significant dose response in efficacy (P <0.01), and the observed bleeding rates were low across the groups. DU-176b is being developed solely by Daiichi Sankyo Company, Limited and the data were presented by lead investigator Dr. Gary Raskob.
This randomized, double-blind comparative study examined the safety and efficacy of four doses of DU-176b (15, 30, 60 and 90 mg once daily) versus the low molecular weight heparin, dalteparin. The study was conducted among 903 patients in Europe and North America undergoing total hip replacement surgery.
"These findings are encouraging and we look forward to further study on this Factor Xa inhibitor," said Gary Raskob, Ph.D., Dean, College of Public Health at the University of Oklahoma Health Sciences Center. "These findings indicate DU-176b may provide a high degree of efficacy, but further study is needed."
"As the company that discovered one of the first Factor Xa small molecules (DX-9065a), we are proud to be building on our innovation in cardiovascular disease and tackling the need for better and more effective ways to prevent thrombosis," said John Alexander M.D., president, Daiichi Sankyo Pharma Development. "We expect to commence phase III studies for DU-176b, targeting patients with atrial fibrillation, before the end of 2008.”
DU-176b is an oral anticoagulant that directly inhibits Factor Xa, a clotting factor in the blood. Daiichi Sankyo is developing DU-176b as a potential new treatment for the prevention of both arterial and venous thromboembolism.
About Daiichi Sankyo
A global pharmaceutical innovator, Daiichi Sankyo Co., Ltd., headed by President Takashi Shoda was established in 2005 through the merger of two leading Japanese pharmaceutical companies, Daiichi Pharmaceutical Co., Ltd. and Sankyo Co., Ltd. This integration created a more robust organization that allows for continuous development of novel drugs that enrich the quality of life for patients around the world. A central focus of Daiichi Sankyo's research and development is cardiometabolic diseases, including therapies for thrombosis, dyslipidemia, hypertension, diabetes, and acute coronary syndromes. Equally important to the company is the discovery of new medicines in the areas of infectious diseases, cancer, bone and joint diseases, and immune disorders. For more information, visit www.daiichisankyo.com.‹
[Updated for DU-176b data. Please see MNTA ‘ReadMeFirst’ for M118.]
General #msg-25160571 Anticoagulant market has large potential (WSJ) #msg-26899903 Anticoagulant market has large potential (graphic) #msg-26451612 Venous thromboembolism is a big, big problem #msg-18759853 Overview of the new oral anticoagulants #msg-26701803 Technical overview of traditional anticoagulants
Xarelto (rivaroxaban) #msg-30972846 EMEA approves Xarelto for VTE prevention #msg-31857009 Bayer accelerates Xarelto development #msg-31073048 JNJ submits NDA for VTE prevention #msg-29662519 Rivaroxaban rationale #msg-24337258 Bayer plans 50,000(!)-patient study
Apixaban #msg-31742223 Apixaban fails vs Lovenox in phase-3 #msg-19134406 PFE, BMY ink $1B collaboration #msg-29928836 Seventh and eighth phase-3 trials begin #msg-21044973 Apixaban non-inferior to Warfarin in phase-2
Pradaxa (dabigatran) #msg-27956748 Pradaxa approved for VTE prevention in EU #msg-26086079 BI completes enrollment of huge AF trial #msg-25152872 BI starts phase-2 in ACS #msg-21155926 Dabigatran non-inferior to Lovenox in VTE prevention
Lovenox #msg-11669012 Lovenox more cost-effective than heparin? #msg-10569101 Arixtra bests Lovenox in ACS
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