FDA approves reversal agent for dabigatran

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The FDA approved idarucizumab on Oct. 16 for patients who need to reverse the blood-thinning effects of dabigatran. Boehringer Ingelheim manufactures and markets idarucizumab and dabigatran.

The FDA approved idarucizumab (Praxbind) under its accelerated approval program and granted the medication a breakthrough therapy designation.

In 2010, the FDA approved dabigatran (Pradaxa), a direct thrombin inhibitor intended to prevent stroke and systemic blood clots in patients with atrial fibrillation. It is also approved to treat and prevent deep venous thrombosis and pulmonary embolism.

The approval of idarucizumab was based on three studies that included 283 healthy volunteers who received dabigatran. The FDA noted that one study found patients who received idarucizumab had an immediate reduction in the amount of dabigatran in their blood. Another ongoing trial found 89 percent of patients who received idarucizumab had a full reversal in the anticoagulant effect of dabigatran within four hours.

Boehringer Ingelheim mentioned in a news release that the most common adverse events in patients receiving idarucizumab were headache, hypokalemia, delirium, constipation, pyrexia and pneumonia.