Anticoagulant Reversal Drug Awarded Accelerated Approval by FDA

Anticoagulant Reversal Drug Awarded Accelerated Approval by FDA
October 19, 2015

A reversal agent for an anticoagulant may be able to hit the market earlier than expected.

The Food and Drug Administration (FDA) has granted an accelerated approval to Praxbind (idarucizumab). The drug was developed for use in patients who are taking the anticoagulant Pradaxa (dabigatran) during emergency situations when there is a need to reverse its 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," Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said in a written 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."

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 solution is for intravenous injection.

The efficacy of Praxbind was demonstrated in a trial including 123 patients. In 89 percent of these participants, the anticoagulant effect of Pradaxa was fully reversed within four hours. The most common side effects resulting from this trial were low potassium (hypokalemia), confusion, constipation, fever and pneumonia.

Praxbind qualifies for the FDA's accelerated approval program as it fills an unmet medical need. 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.

Praxbind and Pradaxa are both marketed by Boehringer Ingelheim.