Novel anticoagulant therapy receives fast track designation from FDA
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Merck announced its investigational factor XI inhibitor to reduce risk for major thrombotic CV events in patients with end-stage renal disease has received fast track designation from the FDA.
The agent (MK-2060), a monoclonal antibody, is currently being evaluated in a phase 2 study in patients with end-stage renal disease on hemodialysis, according to a press release from the company.
“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 and head of global clinical development, chief medical officer, Merck Research Laboratories, said in the release. “We are encouraged by this fast track designation because additional anticoagulation medicines are urgently needed for patients with end-stage renal disease 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 fast track designation is granted to therapies with the potential to fill unmet needs of patients with serious medical conditions. It includes the ability for the developer to have more frequent interactions with the agency, and potentially future accelerated priority review and accelerated approval.
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