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FDA Approves Pradaxa for Prophylaxis of Deep Venous Thrombosis and Pulmonary Embolism after Hip Replacement Surgery

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.”

The FDA approval is based on the results of two randomized, double-blind, phase III trials in patients undergoing total hip replacement, RE-NOVATE™ and RE-NOVATE II™. In RE-NOVATE, 3,494 patients were randomized to three groups receiving prophylactic treatment with one of two doses of Pradaxa (220 mg or 150 mg) once daily or enoxaparin 40 mg once daily for 28 to 35 days. The first Pradaxa group was given a dose of 110 mg on the day of surgery and 220 mg daily thereafter; the second Pradaxa group received a dose of 75 mg on the day of surgery and 150 mg daily thereafter. In RE-NOVATE II, 2,055 patients were randomly assigned prophylactic treatment for 28 to 35 days with Pradaxa 220 mg once daily or enoxaparin 40 mg once daily. Patients receiving Pradaxa were treated with a dose of 110 mg on the day of surgery and 220 mg daily thereafter. The results of RE-NOVATE showed patients taking Pradaxa 220 mg had a lower composite total of venous thromboembolism (VTE, which comprises DVT and PE) and all-cause death (6.0 percent) than those on enoxaparin 40 mg (6.7 percent). In RE-NOVATE II, the composite total of VTE and all-cause death occurred in 7.7 percent of patients in the Pradaxa group vs. 8.8 percent of patients in the enoxaparin group.

There were higher rates of major bleeding in RE-NOVATE (2.0%, 1.6%) and RE-NOVATE II (1.4%, 0.9%) with 220 mg vs. enoxaparin. In the two studies, the rate of major gastrointestinal bleeds in patients receiving Pradaxa and enoxaparin was the same (0.1%) and for any gastrointestinal bleeds was 1.4% for Pradaxa and 0.9% for enoxaparin. The most common adverse events in both studies were gastrointestinal disorders. Incidence was the same across the Pradaxa and enoxaparin treatment groups (39.5%). Dyspepsia (including abdominal pain upper, abdominal pain, abdominal discomfort, and epigastric discomfort) occurred more frequently among patients receiving Pradaxa (4.1%) compared to enoxaparin (3.8%). Gastritis-like symptoms (including gastritis, GERD, esophagitis, erosive gastritis and gastric hemorrhage) were less common in patients receiving Pradaxa (0.6%) compared to enoxaparin (1.0%). Clinical MI was reported in 2 (0.1%) Pradaxa patients and 6 (0.3%) enoxaparin patients.

“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.

About the Boehringer Ingelheim Cares Foundation Patient Assistance Programs

For more than 125 years, Boehringer Ingelheim has been focused on improving the lives of patients. In keeping with the company commitment to do the most good for the most people, Boehringer Ingelheim works hard to ensure its medicines are accessible to everyone who needs them, including senior citizens and families on limited incomes. The Boehringer Ingelheim Cares Foundation Patient Assistance Programs (BI-PAP) make Boehringer Ingelheim medicines available free of charge to patients who are without pharmaceutical insurance coverage, and who meet certain household income levels.

About Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation.

Boehringer Ingelheim is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with 146 affiliates and more than 47,000 employees. Since its founding in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel treatments for human and veterinary medicine.

Boehringer Ingelheim is committed to improving lives and providing valuable services and support to patients and families. Our employees create and engage in programs that strengthen our communities. To learn more about how we make more health for more people, visit our Corporate Social Responsibility Report.

In 2014, Boehringer Ingelheim achieved net sales of about $16.96 billion dollars (13.3 billion euros). R&D expenditure corresponds to 19.9 percent of its net sales.

For more information please visit www.us.boehringer-ingelheim.com, or follow us on Twitter @BoehringerUS.

Boehringer Ingelheim Pharmaceuticals, Inc. either owns or uses the trademarks Pradaxa® and PRADAXA with associated design®, RE-NOVATE™ and RE-NOVATE II™ under license.

Source: Boehringer Ingelheim Pharmaceuticals, Inc.

Posted: November 2015

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