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.
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