Original from: Bussinesswire
Merck, (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Merck¡¯s investigational anticoagulant therapy MK-2060 for the reduction in risk of major thrombotic cardiovascular events in patients with end-stage renal disease (ESRD). According to the FDA, Fast Track is a process designed to facilitate the development and expedite the review of drug candidates to treat serious conditions and fulfill an unmet medical need. A therapeutic candidate that receives Fast Track designation may be eligible for more frequent interactions with the FDA to discuss the candidate¡¯s development plan and, if relevant criteria are met, eligibility for Accelerated Approval and Priority Review.
¡°At Merck we are focusing our efforts where the needs are greatest, and we believe we have a significant opportunity with MK-2060 for the potential prevention of thrombosis in patients with advanced forms of kidney disease,¡± said Dr. Eliav Barr, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. ¡°We are encouraged by this Fast Track designation because additional anticoagulation medicines are urgently needed for patients with ESRD who are susceptible to high rates of life-threatening thrombotic events as well as high bleeding risk. Today there is no anticoagulation standard of care for such patients.¡±
MK-2060 is an investigational monoclonal antibody designed to inhibit Factor XI and its ability to activate downstream proteins involved in the blood coagulation cascade. MK-2060 is currently being evaluated in a Phase 2 study for the treatment of patients with ESRD receiving hemodialysis.
Earlier this year Merck highlighted its broad and growing cardiovascular portfolio and pipeline at an investor event, where MK-2060 was featured.
