Merck Gets FDA Fast-Track Designation for MK-2060 Anticoagulant Therapy
August 23 2022 - 7:39AM
Dow Jones News
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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