FDA files sDNA for Pradaxa

RIDGEFIELD, Conn. — Boehringer Ingelheim Pharmaceuticals on Monday announced that the Food and Drug Administration has filed a supplemental new drug application for Pradaxa (dabigatran etexilate mesylate) to prevent deep venous thrombosis and pulmonary embolism in patients who have had hip replacement surgery. If the sNDA is granted approval, this will mark the fourth indication for the drug.

 

According to the company, almost 300,000 hip-replacement surgeries are performed each year in the United States, without preventative treatment, incidences of DVT range from 40% to 60%. Fatal PE occurs in one-of-500 patients, the company said. 

 

“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, SVP, Medicine and Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals. “The acceptance of this sNDA is another step toward expanding the therapeutic uses for Pradaxa to improve patient outcomes in this population.”

 

Pradaxa first received FDA approval in 2010 and was approved for two additional indications — including the treatment of DVT and PE — in 2014.