Physicians' Academy for Cardiovascular Education

EMA fast-tracks antidote to anticoagulant effect of dabigatran

News - Sep. 29, 2015

The European Medicines Agency (EMA) has recommended granting a marketing authorisation for idarucizumab as a specific antidote to the anticoagulant medicine dabigatran etexilate, 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.

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. Idarucizumab is the first medicine designed to specifically neutralise the anticoagulant effect of one of the non-vitamin K oral anticoagulants (NOACs), namely dabigatran.

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’s anticoagulant effect within 5 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 idarucizumab’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 opinion adopted by the CHMP at its September 2015 meeting is an intermediary step on idarucizumab’s path to patient access. 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.

Press release EMA September 25, 2015

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