Novel Anticoagulant Therapy Receives FDA Fast Track Designation for End Stage Renal Disease

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The investigational therapy is being evaluated in a phase 2 study for the reduction in risk of major thrombotic cardiovascular events in patients with ESRD on hemodialysis.

The US Food and Drug Administration (FDA) has granted Fast Track designation for an anticoagulant therapy MK-2060 for the reduction in risk of major thrombotic cardiovascular events in patients with end-stage renal disease (ESRD). The ongoing phase 2 study is evaluating the impact of the treatment on this patient population who are receiving hemodialysis.

Merck shared the news about its monoclonal antibody in an announcement today. The novel therapy was designed to inhibit Factor XI and therefore halt the factor's ability to activate downstream proteins involved with the blood coagulation cascade.

“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,” Eliav Barr, MD, Senior Vice President, Head, Global Clinical Development, Chief Medical Officer, Merck Research Laboratories, said in a statement.

The FDA offers more time to discuss and evaluate therapeutic candidates with this designation which can help to progress the timeline for the candidate's development plan. Based on the relevant criteria, eligibility for Accelerated Approval and Priority Review is a possibility if standards are met.

“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," Barr continued. "Today, there is no anticoagulation standard of care for such patients.”

The phase 2 study being conducted on the efficacy and safety of MK-2060 is investigating 2 different doses in patients with ESRD receiving hemodialysis treatment through the method of arteriovenous graft (AVG). Data yielded from the trial will be used to inform dose selection of the therapeutic in future studies.