Anticoagulant antidote idarucizumab gets European regulator’s initial approval

Idarucizumab is the first medicine designed to specifically neutralise the effects of newer anticoagulant dabigatran etexilate.

Idarucizumab, a unique drug which can neutralise the effect of the anticoagulant dabigatran etexilate, is being recommended for marketing authorisation across the EU. In the image, micrograph of a blood clot in the heart

Idarucizumab (Praxbind), a unique drug that can neutralise the effect of anticoagulant dabigatran etexilate (Pradaxa), has been recommended for marketing authorisation by the European medicines safety watchdog.

The drug was given a fast-track assessment by the European Medicines Agency (EMA) on the grounds of addressing unmet need. It is the first medicine specifically designed to rapidly reverse the effects of dabigatran etexilate.

According to the EMA, idarucizumab is expected to be useful in cases where patients have to undergo emergency surgery or when life-threatening or uncontrolled bleeding occurs.

The recommendation was welcomed by Sotiris Antoniou, consultant pharmacist in cardiovascular medicine at Barts Health NHS Trust.

“One of the concerns often raised by clinicians weary of prescribing non-vitamin K antagonist oral anticoagulants (NOACs) is predominantly the lack of reversal agent or antidote,” he says.

“The development of a reversal agent is clearly welcomed to act as a comfort blanket for prescribers (and to patients) who are concerned by the lack of reversal agent albeit the half-life of NOACs is in the region of 10–12 hours in comparison to warfarin, which has a half-life of 45 hours.”

The recommendation follows the results of a clinical trial involving 283 healthy volunteers and another 123 patients who had uncontrolled bleeding or required emergency surgery or procedures.

Researchers found that idarucizumab reversed the effects of dabigatran etexilate within five minutes of being administered and had a long-lasting action that enabled the surgery or procedure to take place.

Mild symptoms suggestive of hypersensitivity have been reported but a causal relationship to idarucizumab could not be established, the EMA says.

Antoniou believes the availability of the reversal agents will further support the drive to ensure patients with atrial fibrillation receive anticoagulation and further reduce the use of aspirin in patients who are deemed unsuitable for warfarin.

“The next step will be for the NHS to ensure the availability of these reversal agents with clear guidelines to ensure those patients who need it can receive it in a timely manner,” he says.

The recommendation from the EMA’s Committee for Medicinal Products for Human Use — which followed its positive opinion — now goes to the European Commission for final approval.

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Citation
The Pharmaceutical Journal, Anticoagulant antidote idarucizumab gets European regulator’s initial approval;Online:DOI:10.1211/PJ.2015.20069449