FDA approves Pradaxa for treatment, reduction in risk of recurrence of DVT, PE

FDA approved dabigatran etexilate mesylate (Pradaxa, Boehringer Ingelheim Pharmaceuticals) for treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with a parenteral anticoagulant for 5 to 10 days, and to reduce the risk of recurrent DVT and PE in patients who have been previously treated.

DVT and PE together are referred to as venous thromboembolism (VTE). In the United States, it is estimated that there are an estimated 900,000 DVT and PE events per year, approximately one-third of which result in death from PE.

A DVT occurs when a blood clot blocks the normal flow of blood through a vein, usually in the leg or pelvis, which may lead to swelling or pain in the affected leg. A PE occurs when a DVT, or part of it, breaks off and travels through the bloodstream to the lungs, blocking a vessel. Symptoms of a PE include shortness of breath and chest pain. It may also cause other symptoms like cough, rapid heart rate, and dizziness. A PE can be life-threatening and requires urgent treatment. The standard of care for patients with a DVT or PE has been acute treatment with parenteral anticoagulation therapy, such as low-molecular-weight heparin [LMWH]), followed by long-term treatment with an oral vitamin K antagonist (eg, warfarin).

“DVT and PE place a significant burden on hospitals and managed care decision-makers,” said Sabine Luik, MD, senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim. “With the approval of Pradaxa for the treatment of DVT and PE, and to reduce the risk of recurrent DVT and PE, now these healthcare providers have the option to prescribe Pradaxa for patients with these serious conditions.”

Unlike vitamin K antagonists such as warfarin, treatment with dabigatran etexilate mesylate does not require regular blood monitoring or related dose adjustments and has no dietary restrictions, according to Dr Luik

Dabigatran etexilate mesylate is also the only novel oral anticoagulant with uniform dosing across indications for patients with creatinine clearance greater than 30 mL/min.

“Following a DVT or PE, after at least 5 days of parenteral anticoagulant therapy, healthcare providers can initiate dabigatran etexilate mesylate 150 mg twice daily and have their patients remain on the same dose during the full course of their treatment,” Dr Luik said.

“Any cost savings associated with are dependent on the patient type, the hospital system, or managed care payer,” Dr Luik said. Overall, now with the approval in 3 indications, dabigatran etexilate mesylate can now be prescribed in a broader set of patients which may provide economic and clinical value to payers as they manage oral anticoagulant therapy for nonvalvular atrial fibrillation [NVAF], DVT, and PE populations.”

The approval is based on results from 4 global phase 3 studies evaluating the efficacy and safety of dabigatran etexilate mesylate in the treatment of DVT and PE.

The RE-COVER and RE-COVER II trials included patients with DVT and PE who were treated with parenteral anticoagulant therapy for 5 to 10 days. The trials showed Pradaxa was non-inferior to warfarin in reducing DVT and PE after a median of 174 days of treatment, and was associated with lower rates of overall bleeding and a higher rate of any gastrointestinal (GI) bleeding (3.1% vs 2.4%). RE-MEDY, which included patients who had been previously treated for an acute DVT and PE with anticoagulant therapy for 3 to 12 months, showed Pradaxa was non-inferior to warfarin in reducing DVT and PE after a median of 534 days of treatment, and was associated with lower rates of overall bleeding and a higher rate of any GI bleeding (3.1% vs 2.2%).

RE-SONATE, which included patients who had been previously treated for an acute DVT and PE with anticoagulant therapy for 6 to 18 months, showed Pradaxa reduced the risk of DVT and PE recurrence by 92% compared to placebo after a median of 182 days of treatment: 0.4% vs 5.6%; HR=0.08 [CI 0.02, 0.25]. Pradaxa was associated with higher rates of any bleeding (10.5% vs 6.1%; HR=1.77 [CI 1.20, 2.61]), clinically relevant non-major bleeding (5.0% vs 2.0%; HR=2.54 [CI 1.34, 4.82]), and GI bleeding (0.7% v. 0.3%) compared to placebo.

Pradaxa is also approved to reduce the risk of stroke in patients with NVAF, and 8 million prescriptions for Pradaxa 150 mg and 75 mg have been filled for more than 850,000 NVAF patients in the United States since its approval in October of 2010.