Boehringer Ingelheim’s Pradaxa gets new indication

RIDGEFIELD, Conn. — Boehringer Ingelheim Pharmaceuticals on Monday announced that it had received final approval from the Food and Drug Administration for its Pradaxa (dabigatran etexilate mesylate) to be used to prevent deep vein thrombosis or pulmonary embolism in patients who have had hip replacement surgery. The approval is for a new use for the drug, which was launched in 2010.

 

“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,” Boehringer Ingelheim’s SVP medicine and regulatory Dr. Sabine Luik said. “PRADAXA has the longest real-world experience of any novel oral anticoagulant, and we are dedicated to ongoing research.”

 

The new indication provides another option for the estimated 300,000 patients who will undergo hip replacements in a year.