The FDA announced Friday that it granted accelerated approval to Boehringer Ingelheim's targeted reversal agent Praxbind (idarucizumab) for use in patients who are taking the company's anticoagulant Pradaxa (dabigatran) during certain emergency situations. The agency noted that the injectable drug is the first reversal agent approved specifically to neutralise the effect of Pradaxa when patient bleeding cannot be controlled.
The FDA, which evaluated Praxbind under a priority review , said the decision was based on results from three studies involving a total of 283 healthy volunteers taking Pradaxa. Results demonstrated that participants who were given Praxbind had an immediate reduction in the amount of Pradaxa in their blood, with the effect lasting at least 24 hours. The agency said another study involves 123 patients taking Pradaxa who received Praxbind due to uncontrolled bleeding or emergency surgery. Laboratory testing data from the ongoing trial showed that Pradaxa's anticoagulant effect was fully reversed in 89 percent of patients within four hours of being administered Praxbind.
Sabine Luik, senior vice president of medicine and regulatory affairs at Boehringer Ingelheim, commented that "while we anticipate that Praxbind will be rarely used in clinical practice, the availability of a specific reversal agent has the potential to give physicians and patients added assurance in choosing Pradaxa." Last month, Praxbind also received a positive opinion  from the Committee for Medicinal Products for Human Use of the European Medicines Agency.
Pradaxa was first cleared  in the US in 2010 to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, and was later expanded  to treat and reduce the risk of recurrence of deep venous thrombosis and pulmonary embolism in certain patients. In May 2014, Boehringer Ingelheim said it had agreed to pay $650 million as part of a comprehensive deal  aimed at settling some 4000 state and federal lawsuits in the US alleging that Pradaxa had caused severe and fatal bleeding in patients.
Meanwhile, Portola Pharmaceuticals' investigational andexanet alfa has been shown to reverse the effects of Bayer and Johnson & Johnson's anticoagulant Xarelto  (rivaroxaban), as well as Pfizer and Bristol-Myers Squibb's Eliquis  (apixaban). Portola plans to seek US approval of the Factor Xa inhibitor antidote, which the FDA has designated a breakthrough therapy , before the end of this year.
For related analysis, see ViewPoints: Boehringer Ingelheim poised to leverage idarucizumab to re-energise Pradaxa .