The U.S. Food and Drug Administration Friday approved the first medication designed to reverse the effects of the blood-thinning drug Pradaxa to lower the risk of excessive bleeding during surgery.
Boehringer Ingelheim Pharmaceuticals' drug Praxbind received accelerated approval.
“The anticoagulant effects of Pradaxa are important and life-saving for some patients, but there are situations where reversal of the drug's effects is medically necessary,” said Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research in a released statement. “Today's approval offers the medical community an important tool for managing patients taking Pradaxa in emergency or life-threatening situations when bleeding can't be controlled.”
Pradaxa belongs to a class of anticoagulants called direct thrombin inhibitors, which inhibit the protein thrombin and thin the blood for those at risk for stroke. Many viewed Pradaxa's approval in 2010 as a marked improvement over Warfarin, which has been the standard anticoagulant drug for the past five decades.
Patients taking the drug do not require as much monitoring or need to go on dietary restrictions compared to those using Warfarin. But unlike Warfarin, there was not a way to quickly reverse the effects of direct thrombin inhibitors, making it difficult to stop bleeding during surgeries or medical emergencies.
Approval was based on the results of three clinical trial involving more than 280 healthy subjects who took Pradaxa, according to the FDA. Those studies found an immediate reversal of the effects of Pradaxa in those who took Praxbind for a period of at least 24 hours.
Another trial involving 123 patients taking Pradaxa who took Praxbind for uncontrolled bleeding found it was able to reverse Pradaxa's effects in 89% of patients within four hours of taking the drug.
“We are very pleased to offer Praxbind, the first specific reversal agent for a novel oral anticoagulant,” said Dr. Sabine Luik, senior vice president of Medicine & Regulatory Affairs with Boehringer Ingelheim. “While we anticipate that Praxbind will be rarely used in clinical practice, the availability of a specific reversal agent has the potential to give physicians and patients added assurance in choosing Pradaxa.”
Boehringer Ingelheim did not disclose the price of the drug. But President and CEO Paul Fonteyne said it had been set to "ensure the likelihood that it can be available at institutions where Pradaxa patients seek emergency care."