The European Medicines Agency (EMA) has recommended the approval a specific antidote to reverse the anticoagulant effect of the direct oral thrombin inhibitor dabigatran (Pradaxa): idarucizumab (Praxbind, Boehringer Ingelheim).
The recommendation for approval follows an accelerated assessment from the Committee for Medicinal Products for Human Use (CHMP). Based on its review, the CHMP recommends use of the dabigatran-specific antidote Idarucizumab (Praxbind) in dabigatran-treated patients who need to undergo emergency surgery or when life-threatening or uncontrolled bleeding occurs.
Real-world testing of idarucizumab has shown the agent safely and effectively reverses the anticoagulant effects of dabigatran. In the RE-VERSE AD study, which was recently presented at the European Society of Cardiology 2015 Congress in London, UK, investigators presented positive data when the agent was tested in patients with atrial fibrillation (AF) who needed emergency surgery or intervention. In the same trial, investigators also showed the drug was effective in managing patients with uncontrolled bleeding.
The risk of bleeding has been a concern with dabigatran since the agent was approved by the European Commission in 2008, according to the EMA. In the US, Boehringer Ingelheim reached a settlement in 2014 and paid out $650 million as part of state and federal lawsuits to patients who claimed dabigatran caused serious adverse events, the majority of which were bleeding-related.
Dabigatran is approved in Europe for prevention of stroke and pulmonary embolism in patients with AF as well as for the primary prevention of thromboembolic events in adult patients who have undergone total-hip- or total-knee-replacement surgery. It is also used to treat deep vein thrombosis (DVT) and pulmonary embolism (PE) and to prevent the reoccurrence of DVT/PE.
Although not approved in the US, the Food and Drug Administration has prioritized its review of idarucizumab as part of the accelerated-approval pathway.
The CHMP opinion to recommend approval will now be sent to the European Commission, which will make the final decision on a European Union-wide marketing authorization.
Source: European Medicines Agency. EMA fast-tracks antidote to anticoagulant Pradaxa [press release]. September 25, 2015. Available here.