The US Food and Drug Administration has stamped its seal of approval on Boehringer Ingelheim’s Praxbind, marking the the first time a specific antidote to a novel oral anticoagulant - in this case Pradaxa - has been cleared for the US market.
Praxbind (idarucizumab) is a fully humanised antibody fragment that has demonstrated its ability to completely reverse the anticoagulant effects of Pradaxa (dabigatran) in clinical trials.
The regulator has green-lighted the ‘breakthrough’ drug for use in patients taking Pradaxa when emergency situations arise and necessitate reversal of its blood-thinning effects, such as an urgent need for surgery, offering doctors a new tool to manage uncontrolled bleeding.
“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,” said Sabine Luik, who leads Medicine & Regulatory Affairs at BI.
Praxbind was approved under the FDA’s accelerated approval programme - which enables clearance of drugs that fill an unmet medical need based on an effect on a surrogate or an intermediate clinical endpoint that likely predicts a clinical benefit to patients - after a reduction in unbound Pradaxa and normalisation of coagulation parameters was observed in healthy volunteers.
The drug is also currently being reviewed by regulators in Europe, where it recently received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use, as well as in Canada.