By Chris Wack

 

Merck & Co. said Tuesday that the U.S. Food and Drug Administration has granted fast-track designation for its investigational anticoagulant therapy MK-2060 for the reduction in risk of major thrombotic cardiovascular events in patients with end-stage renal disease.

The FDA's fast-track designation 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 this 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.

 

Write to Chris Wack at chris.wack@wsj.com

 

(END) Dow Jones Newswires

August 23, 2022 07:24 ET (11:24 GMT)

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