Boehringer Ingelheim receives CHMP backing for new Pradaxa reversal agent

Boehringer Ingelheim has announced that idarucizumab, its new reversal agent for Pradaxa, has been recommended for European regulatory approval.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of idarucizumab for rapid reversal of the anticoagulant effects of Pradaxa when required.

It is the first specific reversal agent for a non-vitamin K antagonist oral anticoagulant (NOAC) to gain a CHMP positive opinion. Such agents are sometimes needed for emergency surgery, urgent procedures or in cases of life-threatening or uncontrolled bleeding.

This positive opinion is based on clinical trial results which showed that idarucizumab reverses the anticoagulant effect of Pradaxa within minutes.

If approved by the European Commission, the new product will be sold under the brand name Praxbind.

Professor Jorg Kreuzer, vice-president for medicine within Boehringer Ingelheim's cardiovascular business, said: "I am convinced that the availability of idarucizumab will give physicians and patients added assurance in choosing dabigatran as the first ever NOAC with a specific reversal agent."