Boehringer Ingelheim has announced that the European Commission has licensed idarucizumab (Praxbind) for rapid and specific reversal of the anticoagulant effects of dabigatran etexilate (Pradaxa, Boehringer Ingelheim) in cases of emergency surgery/urgent procedures or in situations of life-threatening or uncontrolled bleeding.
Idarucizumab is the first specific reversal agent for a non-vitamin K antagonist oral anticoagulant (NOAC) to be granted a licence in the European Union.
Steve Austin, lead investigator for REVERSE-AD trial in the UK says: “Anticoagulants offer important benefits to patients. But there are going to be very rare circumstances when rapid reversal is beneficial. Quickly and effectively being able to reverse the anticoagulant effect is therefore a critical consideration for doctors. It has been very pleasing to see the positive effect of idarucizumab use in the UK and Ireland during the REVERSE-AD trial, and I am delighted these data, when added to that of the overall study, has made the authorisation of idarucizumab possible.”
He adds: “It provides myself and my colleagues with further reassurance for safe anticoagulant care for patients here in the UK and Ireland.”
The licensing of idarucizumab by the European Commission follows the positive opinion issued by the Committee for Medicinal Products for Human Use of the European Medicines Agency in September 2015. Idarucizumab was already licensed by the US Food and Drug Administration in October 2015.
The licence is based on data from healthy volunteers, as well as results from an interim analysis of the RE-VERSE AD clinical study. In the studies, the reversal effects of idarucizumab were evident immediately, within minutes after administration of five grams of idarucizumab. Reversal was complete and sustained for at least 12 hours in almost all patients. In the data submitted for authorisation, including 123 patients from RE-VERSE AD and more than 200 volunteers previously given idarucizumab no safety concerns or prothrombotic signals were observed.
“I am delighted that we are now able to offer Praxbind, the only specific reversal agent for a NOAC, to patients and physicians in Europe,” says Jörg Kreuzer, vice president Medicine, Therapeutic Area Cardiovascular, Boehringer Ingelheim. “With this licence, Boehringer Ingelheim is again leading the evolution of anticoagulation care, as we did with the introduction of Pradaxa. And while we anticipate that Praxbind will be rarely used in clinical practice, the availability of this specific reversal agent can now give physicians and patients added confidence when using Pradaxa.”