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Drug Watch: FDA Approves Reversal Agent Praxbind® for the Anticoagulant Pradaxa

The FDA granted “accelerated approval” to Praxbind®, a reversal agent (antidote) to Pradaxa®. Praxbind is given intravenously to patients who have uncontrolled bleeding or require emergency surgery.

The accelerated approval program is designed to provide patients with earlier access to new drugs.

Pradaxa (dabigatran), a novel oral anticoagulant (NOAC), reduces the risk of clots and stroke in patients with Atrial Fibrillation. The new NOACs are alternatives to warfarin (Coumadin).

Patients on Pradaxa Were Bleeding to Death in the ER

Patients on Pradaxa have been bleeding to death in the ER while doctors were powerless to stop their bleeding and could only watch them die. See Stop Prescribing or Taking Pradaxa.

Praxbind - antidote to Pradaxa

Praxbind®, reversal agent for Pradaxa®

In clinical trials, 5gs of Praxbind (idarucizumab) reversed the anticoagulant effect of Pradaxa within minutes (which is significantly faster than the current antidotes for warfarin). In one ongoing trial, the anticoagulant effect of Pradaxa was fully reversed in 89% of patients within four hours. This effect lasted at least 24 hours.

Praxbind works by binding to Pradaxa to neutralize its effect (measured as unbound Pradaxa plasma concentration). The most common side effects of Praxbind were headache, low potassium, confusion, constipation, fever and pneumonia.

Boehringer Ingelheim (a privately-held German company), which manufactures both Pradaxa and Praxbind, will be required to submit additional clinical information after approval to confirm the clinical benefit of Praxbind.

After Praxbind, Get Back on Anticoagulants ASAP!

Boehringer Ingelheim recommends that patients resume their anticoagulant therapy as soon as medically appropriate. In the clinical trials of Praxbind, five patients suffered strokes after reversal. They were not receiving anticoagulant therapy at the time of their stroke.

Other NOACs Will Soon Have a Reversal Agent

Pradaxa was the first NOAC to win FDA approval, but now there are three other new anti–blood clotting drugs available to doctors and patients.

Despite its newly approved reversal agent, Pradaxa’s advantage over the other NOACs will probably be short lived.

• Xarelto® (rivaroxaban) by Bayer Pharma/Janssen Pharmaceuticals
• Eliquis® (apixaban) by Pfizer/Bristol-Meyers Squibb (tested the best with the best safety record)
• Lixiana®/Savaysa® (edoxaban) by Daiichi-Sankyo (newest NOAC to be approved by the FDA)

The other NOACs will soon have a reversal agent, Andexanet Alfa, which has done well in clinical trials and is also on fast track FDA approval. It’s being developed by Portola Pharmaceuticals.

Despite its newly approved reversal agent, Pradaxa’s advantage over the other NOACs will probably be short lived.

References for this article

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