First reversal agent approved for anticoagulant dabigatran

FDA approved idarucizumab (Praxbind), the first reversal agent for the anticoagulant dabigatran (Pradaxa) that is indicated for emergency situations when bleeding is out of control.

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“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. “[This] approval offers the medical community an important tool for managing patients taking Pradaxa in emergency or life-threatening situations.”

Dabigatran’s reversal agent, which is administered through intravenous injection, works by binding to the drug compound to neutralize its effect.

Safety and efficacy data

Idarucizumab was evaluated in three trials for safety and efficacy with 283 health volunteers who received the anticoagulant dabigatran. The healthy participants were given the reversal agent and the amount of dabigatran in the blood of the volunteers was immediately reduced. That effect lasted for 24 hours. The most common side effect among participants was headache.

In another study, 123 patients who were taking dabigatran were administered idarucizumab for uncontrolled bleeding or emergency surgery. Full reversal of dabigatran was achieved in 89% of patients four hours after administration of the reversal agent. In this trial, the most common side effects included hypokalemia, confusion, constipation, fever, and pneumonia.

FDA noted that patients receiving the reversal agent of dabigatran are at increased risk of blood clots and stroke due to atrial fibrillation. It is recommended that patients resume dabigatran as soon as medically appropriate, according to the labeling of idarucizumab.

Idarucizumab, marketed by Boehringer Ingelheim, was approved under the FDA’s accelerated approval program and the company must submit additional clinical information to confirm the reversal agent’s benefit. Dabigatran, also marketed by Boehringer Ingelheim, was approved in 2010 for the prevention of stroke and blood clots in patients with atrial fibrillation and for the treatment and prevention of deep venous thrombosis and pulmonary embolism.