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  • Conversation: Merck granted fast track designation by FDA for end-stage renal disease therapy

    • August 25, 2022 11:13 AM BST
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      Merck granted fast track designation by FDA for end-stage renal disease therapy

      Merck – known as MSD outside the US and Canada – has received fast track designation from the US Food and Drug Administration (FDA) for MK-2060, an investigational anticoagulant therapy for the reduction of major thrombotic cardiovascular events in patients with end-stage renal disease (ESRD).
      ESRD, also called end-stage kidney disease or kidney failure, occurs when chronic kidney disease — the gradual loss of kidney function — reaches an advanced state to the point that the kidneys can no longer function on their own.
      While anticoagulants such as factor Xa inhibitors work well in lower-risk patients, there remains a need for treatments that can prevent blood clots in individuals who have higher bleeding risks.
      Factor XI, however, is a protein in the blood which is transformed into its active enzyme form – factor XIa – as part of the blood coagulation cascade, and has been identified for potentially safer anticoagulant drugs as factor XI deficiency or inhibition is associated with little or no bleeding.
      MK-2060 is a novel inhibitor of factor XI, administered intravenously, and designed to work through a dual mechanism of action both blocking the activation of factor XI as well as the downstream activity of activated protein.
      The therapy is currently being investigated in a phase 2 study to evaluate the efficacy and safety of two different doses of MK-2060 in participants with ESRD receiving haemodialysis via an arteriovenous graft (AVG).
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