MK-2060 is a monoclonal antibody under development which is intended to block Factor XI's capacity to activate downstream proteins involved in the blood coagulation cascade
Merck's branch office campus in Upper Gwynedd Township, Pennsylvania. (Credit: Montgomery County Planning Commission from Wikipedia)
Pharmaceutical company Merck has received the US Food and Drug Administration (FDA) Fast Track designation for its investigational anticoagulant therapy MK-2060.
The therapy is intended for the reduction in risk of major thrombotic cardiovascular events in patients with end-stage renal disease (ESRD).
If given Fast Track designation, a treatment candidate may be eligible for more regular interactions with the FDA to talk about their development strategy and accelerated approval and priority review.
Merck Research Laboratories chief medical officer Dr Eliav Barr said: “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.
“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.”
MK-2060 is a monoclonal antibody under development which is intended to block Factor XI’s capacity to activate downstream proteins involved in the blood coagulation cascade.
According to the firm, a Phase 2 trial is now evaluating MK-2060 for the treatment of haemodialysis-dependent ESRD patients.
MK-2060, when delivered intravenously, is intended to function by preventing both Factor XI activation and the subsequent activity of the activated protein.
Earlier this month, the company partnered with Orna Therapeutics to discover, develop, and commercialise multiple vaccines and therapeutics programmes.