FDA has informed Merck (NYSE:MRK) that its investigational anticoagulant therapy MK-2060 has received Fast Track designation. The program accelerates the review of new drugs to treat serious conditions or unmet medical need.
The Fast Track designation covers the risk reduction of major thrombotic cardiovascular events in patients with end-stage renal disease (ESRD).
“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,” said Dr. Eliav Barr, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, in a news release. “Today, there is no anticoagulation standard of care for such patients.”
A Phase 2 Study of MK-2060 is now underway in people with end-stage renal disease who are undergoing hemodialysis.