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Pradaxa Reversal Agent Gets Expedited FDA Review

The FDA has agreed to a fast-track review process for a potential reversal agent for the blood thinner Pradaxa, which has been linked to thousands of serious and sometimes fatal injuries due to uncontrollable bleeding events.

Boehringer Ingelheim, the makers of Pradaxa, announced on April 23 that the FDA has announced expedited review for a drug which may be able to rapidly reverse the blood thinning effects of the anticoagulant. The decision means that the drug’s review will be accelerated and, if approved, could get to patients faster than normal for new drugs.

If approved by the FDA, idarucizumab, the name of the reversal agent, would be the first reversal agent to hit the market for a new generation of oral anticoagulants used to prevent strokes in patients with atrial fibrillation. The class, which includes the blockbuster drugs Pradaxa, Xarelto, and Eliquis, has been linked to uncontrollable bleeding events because they were released without antidotes that doctors can use in the event patients suffer hemorrhages or other bleeding events.

The drugs have been promoted as superior replacements for generic warfarin, which has been on the market for many years, with the manufactures of these new generation anticoagulants indicating that they are easier to use and require less frequent blood monitoring. However, unlike warfarin, which can be quickly reversed with a dose of vitamin K and fresh frozen plasma, there are no approved reversal agents for the medications.

The FDA’s standard for granting a Priority Review is that it should apply in cases where a drug can significantly improve the safety or effectiveness of a treatment of serious conditions. The agency previously gave the drug breakthrough status during clinical testing.

The announcement comes just days after Portola Pharmaceuticals announced that testing indicated that its own reversal agent, andexanet alfa, had shown to be effective in reversing the blood thinning effects of Xarelto and Eliquis.  The manufacturer said the phase 3 trials had met both primary and secondary endpoint goals. It has also been granted breakthrough status for development..

Pradaxa (dabigatran) was the first member of this class to hit the market, introduced by Boehringer Ingelheim in October 2010. More than 4,000 Pradaxa lawsuits were filed on behalf of former users who alleged that inadequate warnings about the lack of a reversal agent were provided for consumers and the medical community. Following several years of litigation, a Pradaxa settlement was reached and announced last year, with Boehringer Ingelheim agreeing to pay $650 million to resolve the claims for an average of about $150,000 each.

Xarelto (rivaroxoaban) was introduced in 2011, as the second member of this class, and it has since grown to become the best seller of the two. Bayer and Johnson & Johnson now face a growing number of Xarelto lawsuits which raise nearly identical allegations from former users who suffered severe bleeding problems.

Eliquis (apixaban) was approved by the FDA in early 2013 by Bristol-Myers Squibb.

If you have suffered a serious bleeding event or hemorrhage while taking Xarelto, contact Cliff Rieders, Esq, of the Rieders Travis Firm for a confidential evaluation.