Therapy Areas: Cardiovascular
US Merck Receives Fast Track Designation from the US FDA for Investigational Anticoagulant Therapy MK-2060
25 August 2022 - - The US Food and Drug Administration has granted Fast Track designation for US-based pharmaceutical company Merck's (NYSE: MRK) investigational anticoagulant therapy MK-2060 for the reduction in risk of major thrombotic cardiovascular events in patients with end-stage renal disease.

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.

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.

MK-2060 is a novel inhibitor of Factor XI being investigated for the prevention of thrombosis in patients with end-stage renal disease.

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 being investigated in a Phase 2 study to evaluate the efficacy and safety of two different doses of MK-2060 in participants with ESRD receiving hemodialysis via an arteriovenous graft.

Data from this study will be used to aid dose selection of MK-2060 in future studies.
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