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news.After an end of phase II meeting with the FDA, Medicure is to proceed with a single confirmatory phase III study to gain approval for its drug candidate MC-1 in the reduction of cardiovascular events in patients undergoing coronary artery bypass graft surgery.
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Based on the FDA meeting, Medicure plans to use a composite of cardiovascular death and non-fatal myocardial infarction at post operative day 30 as the primary endpoint for the phase III study. Initiation of this study is targeted for the second half of 2006. MC-1 has received a fast track designation from the FDA.
“MC-1 has the opportunity to be the first product indicated to reduce cardiovascular events associated with ischemia and/or ischemic reperfusion injury in CABG (coronary artery bypass graft) patients, targeting a significant unmet medical need,” said Medicure’s president and CEO, Dr Albert Friesen.
MC-1 is a small molecule that reduces the amount of damage to the heart following ischemia and/or ischemic reperfusion injury. Studies with MC-1 suggest that it does this by protecting cardiomyocytes (heart muscle cells). Since cardiomyocytes are essential for normal heart function and do not regenerate themselves following an ischemic event, their preservation is key to minimizing ischemic damage and maintaining proper heart function.