Merck’s Anticoagulant Therapy Scores Fast Track Designation From FDA

On August 23, Merck announced that the United States Food and Drug Administration (FDA) granted Fast Track designation for MK-2060. MK-2060 is an investigational anticoagulant therapy reducing the risk of major thrombotic cardiovascular events in patients with end-stage renal disease.

Related Article: Potential Novel Anti-thrombotic Treatment by Ionis Pharmaceuticals

End-stage Renal Disease and MK-2060

End-stage renal disease (ESRD) is when a patient’s kidneys permanently cease their function. As a result, a patient requires long-term dialysis or a kidney transplant to stay alive. However, additional complications arise due to ESRD. One of these conditions is thrombosis, which ESRD patients are around 13.92 times more susceptible to than non-ESRD individuals. 

Thrombosis occurs when blood clots form inside the body’s cardiovascular system. When this occurs, these clots block oxygen flow to tissues and organs throughout the body. In addition, they occasionally break apart, traveling to different organs and causing issues there. As a result, thrombosis causes 60,000-100,000 deaths per year.

However, there are multiple treatments for thrombosis. For example, Fesomersen, a drug in development by Ionis Pharmaceuticals, prevents thrombosis by inhibiting a protein called Factor XI. This protein is responsible for coagulation. However, high levels of Factor XI lead to thrombosis.

Merck’s MK-2060 similarly inhibits Factor XI. The anticoagulant therapy not only blocks the activation of the protein but also inhibits the downstream activity of the already activated protein. A Phase 2 study is currently underway, evaluating the efficacy of MK-2060 administered to patients with ESRD receiving hemodialysis.

Due to the potential of MK-2060 fulfilling an unmet medical need, the FDA granted it Fast Track designation.

What does the Fast Track Designation Mean for the Treatment?

The Fast Track designation resulted from a section of The Food and Drug Administration Modernization Act of 1997 (FDAMA). The section of the law instructs the FDA’s facilitation of the development of drugs for treating severe or life-threatening conditions. These drugs must also demonstrate the potential to address unmet medical needs. The selected drugs have more frequent interactions with the FDA and are eligible for Accelerated Approval and Priority Review. Under these criteria, the FDA granted MK-2060 Fast Track designation. 

On the designation, Dr. Eliav Barr, senior vice president and head of global clinical development, chief medical officer at Merck Research Laboratories, said “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.”

Researchers estimate the current Phase 2 clinical trial’s completion by April 2023. The FDA might grant MK-2060 Accelerated Approval and Priority Review if the findings prove fruitful. 

Author

Max Heirich