MUNICH--2 Sep--PRNewswire-AsiaNet/InfoQuest
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 (TSE: 4568) 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
"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
Study Result Details
VTE incidence (%) Bleeding occurrence*** (%)
#95% confidence interval, * p=0.005, **p<0.001, ***Major+Clinically Relevant
About DU-176b
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
SOURCE Daiichi Sankyo
CONTACT: Toshiaki Sai, General Manager, Corporate Communications
Department of Daiichi Sankyo Company, Limited,
+81-3-6225-1126;
or
Kimberly Wix of Daiichi Sankyo, Inc. (United States),
+1-973-695-8338,
mobile +1-908-656-5447;
or
Dr. Felix Munzel of Daiichi Sankyo Europe,
+49-(0)-89-7808-47
Web site: http://www.daiichisankyo.com
Invivoscribe is excited to announce that the LeukoStrat(R) CDx FLT3 Mutation Assay has been approved by the U.S. Food and Drug Administration (FDA) to aid in the selection of patients with newly diagnosed FLT3 -ITD positive acute myeloid leukemia (AML) who may be eligible to receive treatment with Daiichi Sankyo's VANFLYTA(R) (quizartinib). The LeukoStrat CDx FLT3 Mutation Assay identifies FLT3 -ITD positive AML patients who may be treated with this newly approved targeted therapy. US Intended