FDA approves idarucizumab as antidote to dabigatran

The US medicines safety watchdog has given fast-track approval to idarucizumab (Praxbind), a drug that can neutralise the effects of the anticoagulant dabigatran etexilate (Pradaxa). In the image, light micrograph of human blood clotting

The US medicines safety watchdog has given fast-track approval to idarucizumab (Praxbind), a drug that can neutralise the effects of the anticoagulant dabigatran etexilate (Pradaxa).

The decision by the Food and Drug Administration (FDA) comes three weeks after a similar recommendation by the European Medicines Agency (EMA) — the body responsible for approving the licensing of drugs across the European Union.

The FDA’s director of the Office of Hematology and Oncology Products in its Center for Drug Evaluation and Research, Richard Pazdur, says the approval of idarucizumab offers clinicians an “important tool” for managing patients taking dabigatran in emergency or life-threatening situations when bleeding cannot be controlled.

“The anticoagulant effects of [dabigatran etexilate] are important and life-saving for some patients, but there are situations where reversal of the drug’s effects is medically necessary,” he says.

The FDA based its decision on the results of the same clinical trials that influenced the EMA’s recommendation.

Some 283 healthy volunteers — patients who did not require an anticoagulant — were given dabigatran etexilate. Among those who were also given idarucizumab, there was an immediate reduction in the amount of dabigatran etexilate in participants’ blood that lasted for at least 24 hours. Another trial included 123 patients taking dabigatran etexilate who were also given idarucizumab to manage uncontrolled bleeding or because they required emergency surgery. The anticoagulant effect of dabigatran etexilate was completely reversed in 89% of patients within four hours of receiving idarucizumab.

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Citation
The Pharmaceutical Journal, PJ, October 2015, Vol 295, No 7882;295(7882):DOI:10.1211/PJ.2015.20069572