FDA Approves Praxbind to Reverse Anticoagulant Pradaxa

Caroline Cassels

Disclosures

October 16, 2015

The US Food and Drug Administration (FDA) has granted accelerated approval to Praxbind (idarucizumab, Boehringer Ingelheim) to rapidly reverse the blood-thinning effects of the anticoagulant Pradaxa (dabigatran, Boehringer Ingelheim).

"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 Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research.

"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. Praxbind is administered via intravenous injection.

According to the FDA, the safety and effectiveness of Praxbind were studied in three trials involving a total of 283 healthy volunteers taking Pradaxa. In volunteers given Praxbind, there was an immediate reduction in the amount of Pradaxa in participants' blood, which was measured as unbound dabigatran plasma concentration that lasted for at least 24 hours. In this study, the most common adverse effect of Praxbind was headache.

Another trial included 123 patients taking Pradaxa who received Praxbind because of uncontrolled bleeding or because they required emergency surgery. In this ongoing trial, on the basis of laboratory testing, the anticoagulant effect of Pradaxa was fully reversed in 89% of patients within 4 hours of receiving Praxbind. In this trial, the most common adverse effects were hypokalemia, confusion, constipation, fever, and pneumonia.

The Praxbind labeling recommends that patients resume their anticoagulant therapy as soon as medically appropriate, as determined by their healthcare provider.

Praxbind is approved under the FDA's accelerated approval program, which allows the agency to approve drugs for serious conditions that fill an unmet medical need based on an effect on a surrogate or an intermediate clinical endpoint that is reasonably likely to predict a clinical benefit to patients.

The program is designed to provide patients with earlier access to promising new drugs, but the company will be required to submit additional clinical information after approval to confirm the drug's clinical benefit, the FDA says.

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