“The FDA’s Fast Track designation is a significant endorsement of the sizeable medical need for a product like MC-1,” commented Medicure’s president and CEO, Dr Albert Friesen. “The Fast Track designation provides us with the opportunity to expedite the development of MC-1 to commercialization.”
The application for fast track designation was submitted based on the demonstrated clinical efficacy and safety of MC-1 and the unmet medical need the drug addresses. The FDA identified coronary artery disease requiring intervention as a life-threatening disease, and the need for a drug to treat heart attacks and strokes as the rationale for designating MC-1 as a fast track product.
Fast Track designated drugs are eligible for priority review (6 months versus the average 12 months) and/or the review of portions of the marketing application prior to the completion of the final registration package.