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The U.S. Food and Drug Administration on Friday gave accelerated approval to Boehringer Ingelheim's Praxbind (idarucizumab) for use in patients who are taking the anticoagulant Pradaxa (dabigatran) during emergency situations when there is a need to reverse Pradaxa's blood-thinning effects.
"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," Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said in a 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," he added.
The FDA approved Pradaxa in 2010 to prevent stroke and systemic blood clots in patients with atrial fibrillation, as well as for the treatment and prevention of deep venous thrombosis and pulmonary embolism.
Praxbind is the first reversal agent approved specifically for Pradaxa and works by binding to the drug compound to neutralize its effect, the FDA said.
The U.S. Food and Drug Administration on Friday gave accelerated approval to Boehringer Ingelheim's Praxbind (idarucizumab) for use in patients who are taking the anticoagulant Pradaxa (dabigatran) during emergency situations when there is a need to reverse Pradaxa's blood-thinning effects.
"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," Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said in a 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," he added.
The FDA approved Pradaxa in 2010 to prevent stroke and systemic blood clots in patients with atrial fibrillation, as well as for the treatment and prevention of deep venous thrombosis and pulmonary embolism.
Praxbind is the first reversal agent approved specifically for Pradaxa and works by binding to the drug compound to neutralize its effect, the FDA said.
The U.S. Food and Drug Administration on Friday gave accelerated approval to Boehringer Ingelheim's Praxbind (idarucizumab) for use in patients who are taking the anticoagulant Pradaxa (dabigatran) during emergency situations when there is a need to reverse Pradaxa's blood-thinning effects.
"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," Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said in a 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," he added.
The FDA approved Pradaxa in 2010 to prevent stroke and systemic blood clots in patients with atrial fibrillation, as well as for the treatment and prevention of deep venous thrombosis and pulmonary embolism.
Praxbind is the first reversal agent approved specifically for Pradaxa and works by binding to the drug compound to neutralize its effect, the FDA said.