FDA approves first reversal agent for anticoagulant Pradaxa

October 27, 2015

FDA has approved idarucizumab (Praxbind, Boehringer Ingelheim) as the first reversal agent for Pradaxa.

FDA has approved idarucizumab (Praxbind, Boehringer Ingelheim) as the first reversal agent for Pradaxa.

Pradaxa is an anticoagulant that was approved by FDA in 2010 to prevent storke and systemic blood clots in patients with atrial fibrillation, as well as for the treatment and prevention of deep venous thrombosis and pulmonary embolism.

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Praxbind is the first reversal agent approved specifically for Pradaxa and works by binding the drug to neutralize its blood-thinning effects without interfering with the coagulation cascade. Praxbind is available as an intravenous injection and is indicated for patients treated with Pradaxa, when reversal of the anticoagulant effect is needed for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding.

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According to the manufacturer in a company statement: "Praxbind is the first and only specific reversal agent available for a noval oral anticoagulant (Pradaxa). "The availability of a specific reversal agent for Pradaxa helps provide healthcare providers, patients, and caregivers increased assurance in their anticoagulation treatment decisions. We are dedicated to providing widespread access to Praxbind in the rare cases where a patient would potentially need urgent intervention, although we do not expect high volume use.”

Praxbind was approved under FDA’s accelerated approval program, which allows approval of drugs for serious medical condition that fill an unmet medical need based on an effect on a surrogate or an intermediate clinical end point that is reasonably likely to predict a clinical benefit to patients. The company will be required to submit additional information after approval to confirm the clinical benefit.

FDA's approval of Praxbind is based on results from clinical trials that studied 283 healthy volunteers taking Pradaxa. In these participants, there was an immediate reduction in the amount of Pradaxa in the blood that lasted for a period of at least 24 hours. In another ongoing trial, including 123 patients taking Pradaxa who received Praxbind because of uncontrolled bleeding or because they required emergency surgery, the anticoagulant effect of Pradaxa was fully reversed in 89% of participants within 4 hours of receiving the reversal agent.

The most common side effects associated with the use of Praxbind include headache, confusion, constipation, fever, pneumonia, and low potassium levels. After receiving Praxbind, it is recommended that patients resume anticoagulant therapy as soon as medically appropriate due to the risk of blood clots and stroke as a result of reversing the effect of Pradaxa. 

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