RIDGEFIELD, Conn., November 23, 2015 – Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved Pradaxa® (dabigatran etexilate mesylate) for the prophylaxis of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have undergone hip replacement surgery. There are an estimated 300,000 total hip replacement surgeries performed in the U.S. each year. Without preventive anticoagulant treatment, the incidence of DVT ranges from 40 to 60 percent for primary elective hip surgery patients.
“This milestone represents the fourth FDA-approved indication for PRADAXA in five years — a testament to the company’s continued leadership in the evolution of anticoagulation care for patients and clinicians,” said Sabine Luik, MD, senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim. “PRADAXA has the longest real-world experience of any novel oral anticoagulant, and we are dedicated to ongoing research. Physicians and patients choosing PRADAXA may have added assurance knowing that it is the only novel oral anticoagulant with more than five years of use in clinical practice and a specific reversal agent.”
…”Many Americans will undergo hip replacement surgery each year. Proactive anticoagulation is vital for reducing the risk of VTE in these patients and helping to improve patient outcomes,” said Samuel Z. Goldhaber, MD, Director of Brigham and Women’s Hospital’s Thrombosis Research Group and Professor of Medicine, Harvard Medical School. “The FDA approval of this new indication for PRADAXA will help address an important public health need and provide a new therapeutic option for this large patient population.”
PRADAXA was initially approved by the FDA in 2010 to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF). In 2014, the FDA approved two additional indications for PRADAXA for the treatment of DVT and PE in patients who have been treated with a parenteral anticoagulant for five to 10 days, and to reduce the risk of recurrent DVT and PE in patients who have been previously treated…