EMA recommends approval of Boehringer’s antidote to blood thinners

Praxbind, Boehringer Ingelheim’s new antidote to blood thinners, recently earned the nod of the European Medicines Agency, or EMA, which recommended its approval for use in Europe. Also referred to as idarucizumab, the medicine is designed to neutralise the anticoagulant effect of Pradaxa or dabigatran when a patient taking it needs to undergo emergency surgery or when life-threatening or uncontrolled bleeding occurs.

Pradaxa, also manufactured by Boehringer Ingelheim, is among the new generation of oral anticoagulants or medicines that prevent the blood from clotting. Praxbind is the first medicine designed to specifically reverse the anticoagulant effect of Pradaxa. Bleeding is a well-known complication of all anticoagulants, but to date, there has been no specific antidote that addresses the effects of older oral anticoagulants. Praxbind seeks to help patients in some emergency situations where a quick reversal of the anticoagulant effect of Pradaxa is required.

EMA’s Committee for Medicinal Products for Human Use, or CHMP, gave its positive opinion based on data from healthy volunteers as well as results from an interim analysis of clinical trials. In the studies, Praxbind was seen to completely reverse Pradaxa’s anticoagulant effect within minutes after five grammes of the antidote was given to patients. There were no serious adverse events that were noted related to Praxbind, and no pro-coagulant effect was observed after the administration of the medicine.

“Our scientists have worked intensively on idarucizumab for years, so we are now very excited about this recommendation for European approval. I am convinced that the availability of idarucizumab will give physicians and patients added assurance in choosing dabigatran as the first ever NOAC [non-vitamin K antagonist oral anticoagulant] with a specific reversal agent,” said Professor Jörg Kreuzer, vice president of the Therapeutic Area Cardiovascular of Boehringer Ingelheim.

Various health groups have welcomed EMA’s positive opinion in favour of Praxbind’s approval. Professor Fausto Pinto, president of the European Society of Cardiology, said that the approval of specific reversal agents to stop anticoagulant effect immediately when needed is a significant advancement in anticoagulation care.

According to the European Stroke Organisation, through its president, Kennedy Lees, this development will be the icing on the cake for treating stroke patients with anticoagulants. Being able to switch off the anticoagulants' effects almost instantly and safely during emergency situations will reportedly make treatment choices much easier for both doctor and patient.

Praxbind or idarucizumab is currently being reviewed for approval by regulatory authorities worldwide, including the U.S. FDA, according to a press release. Boehringer Ingelheim plans to submit its antidote candidate in all countries where Pradaxa or dabigatran is licenced.

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