Merck Gets FDA Fast Track Status For Chronic Kidney Disease Candidate

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Merck's (NYSE: MRK) lead asset MK-2060 for the reduction in risk of major thrombotic cardiovascular events in patients with end-stage renal disease (ESRD).

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 (AVG).

Dr. Eliav Barr, Senior vice president and Chief medical officer, commented: "At Merck we are focusing our efforts where the needs are greatest, and we believe we have a significant opportunity with MK-2060 for the potential prevention of thrombosis in patients with advanced forms of kidney disease. We are encouraged by this Fast Track designation because additional anticoagulation medicines are urgently needed for patients with ESRD who are susceptible to high rates of life-threatening thrombotic events as well as high bleeding risk.”

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

FDA Fast Track Designation is intended to expedite the development and review of new drugs to treat serious medical conditions that fill unmet medical needs.

A therapeutic candidate that receives Fast Track designation may be eligible for more frequent interactions with the FDA to discuss the development plan and eligible for Accelerated Approval and Priority Review, when relevant criteria are met.

Price Action : Merck shares closed Monday’s trading down 1 percent at $91.17