The European Medicines Agency (EMA) has recommended granting a marketing authorisation, following accelerated assessment, for idarucizumab (Praxbind, Boehringer Ingelheim) as a specific antidote to dabigatran etexilate (Pradaxa, Boehringer Ingelheim) when rapid reversal of its effect is required. Idarucizumab is to be used when a patient taking dabigatran needs to undergo an emergency surgery or when life-threatening or uncontrolled bleeding occurs.
Although low in frequency in patients treated with dabigatran, major and sometimes life-threatening bleeding may occur. However, unlike older oral anticoagulants such as warfarin, up until now there has been no specific means of rapidly neutralising the drug’s effect. Idarucizumab could help patients in some emergency cases where a quick reversal of the anticoagulant effect of Pradaxa is needed. The Committee for Medicinal Products for Human Use (CHMP) decided to speed up the evaluation of this medicine and recommended granting a marketing authorisation following an accelerated assessment, given its potential to respond to an unmet medical need.
In clinical studies carried out in 283 healthy volunteers and 123 patients who had uncontrolled bleeding or required emergency surgery or procedures, idarucizumab enabled complete reversal of dabigatran anticoagulant effect within five minutes of administration with a long-lasting action allowing emergency management of patients as needed, and an overall good safety profile.
The applicant received scientific advice on quality, non-clinical and clinical aspects of Praxbind’s application from the CHMP. This is one of the Agency’s main tools to facilitate and stimulate research and development within the EU.
The CHMP opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation. Once a marketing authorisation has been granted, each Member State will take a decision on price and reimbursement based on the potential role/use of this medicine in the context of its national health system.