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.