CHMP recommends Praxbind (idarucizumab) as a reversing agent for Pradaxa (dabigatran)- Boehringer Ingelheim
On 24 September 2015, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Praxbind,(idarucizumab), a specific reversal agent for dabigatran. Praxbind is intended for use when rapid reversal of the anticoagulant effects of Pradaxa (dabigatran etexilate) from Boehringer Ingelheim, is required in adult patients.
The CHMP's 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.
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