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Boehringer’s Praxbind granted accelerated approved by FDA

Reversal agent for anticoagulant Pradaxa given the nod
FDA

The FDA has approved Boehringer's Praxbind for use when the reversal of anticoagulant Pradaxa is required in emergency situations.

The safety and efficacy of Praxbind (idarucizumab) was studied in three trials involving 283 volunteers taking Pradaxa (dabigatran). In the healthy volunteers who were given Praxbind there was a significant and immediate reduction in the amount of Pradaxa in participants' blood that lasted for at least 24 hours.

Richard Pazdur, director of the office of hematology and oncology products in the FDA's center for drug evaluation and research, said: “The anticoagulant effects of Pradaxa are important and life-saving for some patients, but there are situations where reversal of the drug's effects is medically necessary.

“[This] approval offers the medical community and important tool for managing patients taking Pradaxa in emergency or life-threatening situations when bleeding can't be controlled.”

Another trial of 123 patients taking Pradaxa who received Praxbind due to uncontrolled bleeding or for emergency surgery showed that the anticoagulant effect of Pradaxa was fully reversed in 89% of patients within four hours of receiving Praxbind.

Side effects of the drug however included hypokalaemia (low potassium), confusion, constipation, fever, pneumonia and headache.

Reversing the effect of Pradaxa also exposes patients to the risk of blood clots and stroke from underlying diseases such as atrial fibrillation. Praxbind labelling therefore states patients should resume their anticoagulation therapy as soon as their health care provider deems it appropriate.

The approval will come as good news for Boehringer which will want to position itself as the leader in the novel oral anticoagulant (NOAC) market.

However, competition is also coming from rivals such as Portola Pharmaceuticals, which is currently undertaking phase III trials of andexanet alfa, which has shown to reverse the effect of other NOAC's Eliquis (apixaban), Xarelto (rivaroxaban) and Savaysa (edoxaban). 

Article by
Nikhil Patel

19th October 2015

From: Regulatory

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