Pradaxa antidote receives breakthrough therapy designation from FDA

Boehringer Ingelheim announced that the FDA has granted breakthrough therapy designation to its investigational drug idarucizumab, which is being evaluated as an antidote for its oral anticoagulant dabigatran.

According to a company press release, the FDA designates investigational drugs for serious or life-threatening conditions as breakthrough therapies if preliminary evidence indicates the treatment may be a substantial improvement over existing therapies for at least one clinically significant endpoint. Drugs receiving the designation are eligible for an accelerated approval pathway, according to the release.

In a phase 1 study, researchers showed that idarucizumab achieved immediate, complete and sustained reversal of dabigatran (Pradaxa)-induced anticoagulation in healthy people, according to the release. A phase 3 study, RE-VERSE AD, evaluating idarucizumab in patients taking dabigatran who have uncontrolled bleeding or require emergency surgery or other invasive procedures, is underway, the company stated.

Dabigatran is approved for the reduction of risk for stroke and systemic embolism among patients with nonvalvular atrial fibrillation, for treatment of deep vein thrombosis and pulmonary embolism in patients who have been treated with a parenteral anticoagulant for 5 to 10 days, and for reduction of the risk of recurrence of DVT and PE in patients previously treated for those conditions.

There are currently no FDA-approved antidotes for the effects of a specific novel oral anticoagulant, according to the release.