FDA Files Supplemental New Drug Application for Boehringer Ingelheim's Pradaxa

Boehringer Ingelheim Pharmaceuticals has announced that the FDA filed a supplemental New Drug Application (sNDA) for Pradaxa (dabigatran etexilate mesylate) for the prophylaxis of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have had primary elective total hip replacement surgery. If approved, this will become the fourth indication for Pradaxa.

It is estimated that nearly 300,000 total hip replacement surgeries are performed each year in the US. Without prophylaxis (e.g., anticoagulation treatment to prevent blood clots), the incidence of DVT detected by venography (x-ray visualization of the veins after administering injectable contrast dye) ranges from 40% to 60% of primary elective hip surgery patients, and fatal PE occurs in approximately one of 500 patients.

"Total hip replacement is a common procedure, and preventive anticoagulant treatment is recommended because of the potential for DVT and PE, which can be life-threatening for some patients," said Sabine Luik, MD, senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "The acceptance of this sNDA is another step toward expanding the therapeutic uses for Pradaxa to improve patient outcomes in this population."

The submission to the FDA is based on the results of two randomized, double-blind, phase III trials, RE-NOVATE and RE-NOVATE II. The studies compared the efficacy and safety of Pradaxa to enoxaparin in preventing venous thromboembolism (VTE) and death in patients undergoing total hip replacement surgery.