The FDA gave accelerated approval to Praxbind (idarucizumab). For those on Pradaxa, a new gen anti-coagulant with high risk of uncontrollable, even fatal, bleeding event, this is great news. Why? Praxbind is the Pradaxa antidote. Up to this point, there was no way to reverse Pradaxa’s effects short of multiple blood transfusions to remove the drug from a patient’s system.The FDA accelerated approval process gives the agency the power to fast track certain drugs through the typical approval needed to get to market. Drugs in this program are said to be only for serious conditions that are currently not being addressed. This approval is based on how the drug performs in initial clinical trials. Praxbind’s maker, Boehinger Ingelheim, still needs to give the FDA post-approval clinical information in order to confirm Praxbind’s benefit. Boehringer also makes Pradaxa.According to Dr. Richard Pazdur, M.D., the director of the Office of Hematology and Oncology Products at the FDA’s Center for Drug Evaluation and Research, “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. Today’s approval offers the medical community an important tool for managing patients taking Pradaxa in emergency or life-threatening situations when bleeding can’t be controlled.”Not every drug that gets accelerated approval actually fulfills the agency’s own requirements. However, in this case, an antidote to Pradaxa certainly fits the bill. Praxbind is given intravenously and works by binding itself to Pradaxa and neutralizing it. The drug is the first and, so far only, Pradaxa antidote.Praxbind’s safety and efficacy was studied in three trials with 238 healthy volunteers who were given Pradaxa and 123 patients on Pradaxa who actually needed the drug. When Praxbind was administered to the healthy volunteers, researchers found an immediate drop in the amount of Pradaxa in their blood. This reduction lasted for at least 24 hours. The most common side effect was headache.The 123 Pradaxa patients who got Praxbind needed it as they were having either uncontrolled bleeds or emergency surgery. This trial is ongoing and has thus far shown appreciable success. The time to full Pradaxa reversal in 89% of patients was within four hours. The most common side effects were confusion, constipation, low potassium (hypokalemia), fever and pneumonia.It is recommended that patients who have taken Praxbind to reverse the effects of Pradaxa should begin taking Pradaxa again as soon as medically appropriate, based on their health care provider’s determination.Source:

FDA approves Praxbind, the first reversal agent for the anticoagulant Pradaxa