First direct thrombin inhibitor cleared for DVT prevention

March 15, 2010

The FDA-approved Iprivask (desirudin for injection, Canyon Pharmaceuticals), now available, marks the first direct thrombin inhibitor (DTI) OK'd for the prevention of deep vein thrombosis (DVT).

The FDA-approved desirudin for injection (Iprivask, Canyon Pharmaceuticals), now available, marks the first direct thrombin inhibitor (DTI) available for the prevention of deep vein thrombosis (DVT).

The drug works by directly inhibiting thrombin, an essential protein in blood clotting.

In clinical trials, desirudin was found to be more effective than heparin and low-molecular weight heparin (LMWH) enoxaparin for preventing proximal DVT and for major venous thromboembolic events (VTE) after elective hip replacement surgery.

“Significant need exists in the U.S. for alternatives to heparin-based anticoagulants that are more effective and easier to use than currently available DTIs. Desirudin becoming available is a step forward in that direction,” said Craig Kessler, MD, Georgetown University professor of medicine and pathology and section chief of hematology, in a statement.

Because desirudin is given as a fixed subcutaneous dose, “it is easier to use than intravenous DTIs and provides a safer alternative for DVT prophylaxis,” added Dr. Kessler.

“Iprivask is a promising advance because it is superior to the current standard of care in preventing proximal DVT and major VTE, with no difference in bleeding,” said Dawn Bell, PharmD, senior vice president and general manager of Canyon Pharmaceuticals, in a statement. “It does not have a risk for thrombocytopenia or heparin-induced thrombocytopenia, is relatively short-acting, and is easy to monitor."

In trials of 2,159 patients undergoing elective hip replacement surgery, adverse events in decreasing order of occurrence included thrombosis, hypotension, leg edema, fever, decreased hemoglobin, hematuria, dizziness, epistaxis, vomiting, impaired healing, cerebrovascular disorder, leg pain, and hematemesis.