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A Novel Oral Anticoagulant is Planned to be Developed for Patients with Prosthetic Heart Valves or Chronic Renal Dysfunction
Date:3/8/2013

tic variant of this enzyme.

"Tecarfarin was specifically designed not to be metabolized by any CYP enzymes, which means it may require less monitoring than warfarin. Some monitoring, according to experts, may still be needed to ensure patient compliance. Data from EMBRACE-AC trial showed that tecarfarin is a more effective OAC than warfarin in patients with a CYP2C9 genetic variant taking at least one CYP2C9 inhibitor despite close monitoring," said Dr Peter Milner , Executive Chairman of Armetheon and partner at AshHill Pharmaceutical Investments.  He added, "for approval of tecarfarin, we anticipate only one more pivotal clinical trial will be required which could be a 'real world', open label study involving about 2500 pre-defined patients."

Recent research indicates that patients with chronic renal dysfunction or failure have reduced or variable activity of CYP enzymes such as CYP2C9 and CYP3A4 as well as the transporter permeability glycoprotein (P-gp). This may explain warfarin's suboptimal performance in this patient population. Currently marketed novel non-monitored OACs (in particular, Factor Xa inhibitors) are eliminated via the kidney and most of them are metabolized via CYP3A4 enzymes in addition to interacting with the P-gp. This may explain the significant variability in anticoagulation response to the novel non-monitored OACs in patients with chronic renal dysfunction or failure.

"Genetic and other sources of variability in the drug metabolizing enzymes CYP3A4 and CYP2C9 or transport related proteins such a P-gp could lead to unpredictable variability in plasma levels of drugs that are metabolized/eliminated through these pathways, particularly if they are used with concomitant medications that may be inhibitors of these metabolic/elimination pathways," said Professor Leslie Z. Benet , former Chairman and Professor of Biopharmaceutical Sciences at University of
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SOURCE Armetheon, Inc.
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