Corautus Genetics Receives FDA Fast Track Designation for VEGF-2
Richard E. Otto, President and Chief Executive Officer of Corautus explained, "The Fast Track application was submitted based upon the large unmet medical need that our VEGF-2 program addresses. Severe angina resulting from coronary artery disease is a serious, debilitating and potentially life threatening disease. We are pleased the FDA determined that our VEGF-2 program warranted this designation, and we looking forward to working with FDA to advance our clinical strategy."
Under the FDA Modernization Act of 1997, the Fast Track program was created to facilitate the development and expedite the review of new therapeutics that are intended to treat serious or life threatening diseases, and that demonstrate the potential to address unmet medical needs. Fast Track designated therapeutics 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.
Corautus' GENASIS (GENetic Angiogenic Stimulation Investigational Study) clinical trial is the largest cardiovascular study of its kind and is evaluating the safety and efficacy of VEGF-2 for the treatment of severe angina associated with cardiovascular disease.
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