CHMP grants positive opinion for idarucizumab, the specific reversal agent for dabigatran etexilate

29-Sep-2015 - Germany

The Committee for Medicinal Products for Human use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending European approval of idarucizumab (to be marketed as Praxbind®). Idarucizumab is intended for use in adult patients treated with Pradaxa® (dabigatran etexilate) when rapid reversal of its anticoagulant effects is required for emergency surgery / urgent procedures or in life-threatening or 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.

“Our scientists have worked intensively on idarucizumab for years, so we are now very excited about this recommendation for European approval”, said Professor Jörg Kreuzer, Vice President Medicine, Therapeutic Area Cardiovascular, Boehringer Ingelheim. “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. Boehringer Ingelheim plans to submit idarucizumab in all countries where dabigatran is licensed.

https://www.bionity.com/en/news/154763/chmp-grants-positive-opinion-for-idarucizumab-the-specific-reversal-agent-for-dabigatran-etexilate.html