The Committee for Medicinal Products for Human use (CHMP) of the European Medicines Agency has issued a positive opinion recommending European approval for the use of idarucizumab when needing to quickly revere the effects of dabigatran etexilate (Pradaxa).
It means idarucizumab is the first reversal agent for a non-vitamin K antagonist oral anticoagulant (NOAC) to gain CHMP positive opinion. The approval follows the results of a clinical trial that showed that idarucizumab reverses the anticoagulant effect of dabigatran within minutes.
Idarucizumab is intended for use in adult patients treated with dabigatran etexilate when rapid reversal of its anticoagulant effects is required when dealing with emergency surgery or in life-threatening situations or if there is a case of uncontrolled bleeding.
The CHMP positive opinion was based on data from healthy volunteers, as well as results from an interim analysis of the RE-VERSE AD trial. In the studies, the reversal effects of idarucizumab were evident immediately, within minutes after administration of 5 grams of idarucizumab. Reversal was complete and sustained in almost all patients. No serious adverse events considered causally related to idarucizumab were identified. Additionally, no pro-coagulant effect was observed after the administration of idarucizumab.
“The CHMP positive opinion in favour of idarucizumab approval is an important recommendation in the field of anticoagulation care,” said Professor Fausto J. Pinto, University of Lisbon, Portugal, and President of the European Society of Cardiology. “The introduction of non-vitamin K antagonist oral anticoagulants, or NOACs, already marked a significant advancement in anticoagulation care. The approval of specific reversal agents to stop their anticoagulant effect immediately when needed will be the next advancement.”
Professor Kennedy R. Lees, University of Glasgow, UK, and President of the European Stroke Organisation, added:“This will be the icing on the cake for treating our stroke patients with anticoagulants like dabigatran: in an emergency we will be able to switch off their treatment almost instantly, and safely. This will make treatment choices much easier for both doctor and patient.”
Professor Jörg Kreuzer, Vice President Medicine, Therapeutic Area Cardiovascular, Boehringer Ingelheim, said: “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 with a specific reversal agent.”
Idarucizumab is currently being reviewed for approval by regulatory authorities worldwide, including the U.S. FDA. Idarucizumab will hopefully be used in all countries where dabigatran is licensed, Boehringer Ingelheim has said.