FDA fast tracks Merck anticoagulant

Aug. 23, 2022

The U.S. FDA has granted Fast Track designation for Merck’s investigational anticoagulant therapy MK-2060, giving Merck a push in its quest to provide new standard-of-care treatment for end-stage renal disease (ESRD) patients.

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. Merck sees a significant opportunity with the drug candidate 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. Today there is no anticoagulation standard of care for such patients,” said Eliav Barr, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.

MK-2060 is currently being evaluated in a phase 2 study for the treatment of patients with ESRD receiving hemodialysis. The Fast Track designation makes Merck eligible for more frequent interactions with the FDA and opens the possibility for  Accelerated Approval and Priority Review.

In the ESRD space, Bayer and Ionis are currently partnered on their own Factor XI antisense inhibitor — announcing positive results from a phase 2b trial last month.