Eisai heart drug may lower heart risks

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Japanese drugmaker Eisai's blood clot candidate E5555 may be able to reduce heart attacks, strokes and cardiovascular deaths without increased serious bleeding risks, researchers say.

Scientists evaluated E5555, a new protease-activated receptor 1 inhibitor, in two Phase II trials in Japanese patients to assess the drug's safety and tolerability. The researchers also wanted to determine its effects on major adverse cardiac events (MACE) and platelet aggregation in acute coronary syndrome and coronary artery disease.

Principal investigator Professor Shinya Goto says the data indicate E5555 may have the potential to reduce MACE with no increase in serious bleeding events even with addition to standard care in both ACS and CAD patients. Although there was a numerical trend towards an increase in bleeding with ascending treatment dose of E5555, this was not statistically significant, according to a release.  The data were presented Monday at the European Society of Cardiology (ESC) Congress.

"From these results, PAR-1 receptor antagonism may be an attractive pathway in the treatment of atherothrombosis," Goto says in a statement. "But we need further adequately powered trials to determine the efficacy and safety of E5555." He notes that E5555 is worth taking into Phase III studies, but adds he doesn't  know if Eisai has such plans, Reuters reports. Eisai is one of a number of drugmakers trying to develop drugs to compete in a market dominated by Sanofi-Aventis and Bristol-Myers Squibb's mega-blockbuster Plavix.

- read the statement from the ESC
- get more from Reuters

ALSO: Eisai has received notification from the FDA that the agency expects to complete priority review of the eribulin mesylate NDA for locally advanced or metastatic breast cancer on or before December 30, 2010, which is a three month extension from the original Prescription Drug User Fee Act action date of Sept. 30. Eisai release 

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