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Merck Gains Fast Track Designation for Its Investigational Anticoagulant

Merck Gains Fast Track Designation for Its Investigational Anticoagulant

Merck’s investigational anticoagulant therapy MK-2060 has received Fast Track designation from the FDA for reducing the risk of major thrombotic cardiovascular events in patients with end-stage renal disease.

MK-2060 is a monoclonal antibody designed to inhibit Factor XI and its ability to activate downstream proteins involved in the blood coagulation cascade.

The investigational therapy is currently being evaluated in a phase 2 study for the treatment of patients with end-stage renal disease who are receiving hemodialysis.

The Fast Track process facilitates development and expedites reviews of drug candidates that treat serious conditions and fulfill an unmet medical need.

September 2, 2022

https://www.fdanews.com/

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