Novel Anticoagulant Therapy for Patients With ESRD Gets Fast Track Status

The Food and Drug Administration (FDA) has granted Fast Track designation to MK-2060 for the reduction in risk of major thrombotic cardiovascular events in patients with end-stage renal disease (ESRD).

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

The Company is currently investigating the efficacy and safety of MK-2060 for the treatment of patients with ESRD who are receiving hemodialysis via an arteriovenous graft (AVG) in a phase 2 trial (ClinicalTrials.gov Identifier: NCT05027074). The primary endpoint of the study is time to first AVG thrombosis event, defined as the sudden occlusion of the participant’s AVG requiring thrombectomy/thrombolysis, or clinical evidence of thrombosis with surgical, radiological or pathological conformation of an AVG thrombosis.

“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,” said Dr Eliav Barr, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “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. Today there is no anticoagulation standard of care for such patients.”

The FDA’s Fast Track designation allows for expedited review of therapies that are meant to treat serious or life-threatening conditions. Generally, the designation is granted to therapies that are expected to have an impact on factors such as survival and daily functioning.

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