Merck Investigational Anticoagulant Therapy MK-2060 gets USFDA fast track designation
MK-2060 is a novel inhibitor of Factor XI being investigated for the prevention of thrombosis in patients with end-stage renal disease (ESRD).
Rahway: Merck, known as MSD outside the United States and Canada, has announced that the U.S. Food and Drug Administration (USFDA) has granted Fast Track designation for the company'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."
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MK-2060 is a novel inhibitor of Factor XI being investigated for the prevention of thrombosis in patients with end-stage renal disease (ESRD). MK-2060, administered intravenously, is designed to work through a dual mechanism of action both blocking the activation of Factor XI as well as the downstream activity of activated protein. MK-2060 is currently being evaluated in a Phase 2 study for the treatment of patients with ESRD receiving hemodialysis.
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