Pradaxa Antidote Receives Full FDA Approval for Reversal of Bleeding Problems

Boehringer Ingelheim has announced that final FDA approval has been received for Praxbind, an antidote for the blood thinner Pradaxa, which helps prevent cases of uncontrollable bleeding that have resulted in thousands of serious problems since Pradaxa was first introduced. 

The FDA granted accelerated approval for the Pradaxa antidote in October 2015, and hinged full approval on the outcome of phase III clinical trials, which were completed last year. According to a press release issued this week, the FDA has now granted full approval for Praxbind.

The action comes amid continuing concerns about the risk of bleeding problems with Pradaxa and other members of the same new-generation of oral anticoagulants, which also include Xarelto and Eliquis.

According to a recent analysis of adverse event reports received by the FDA in 2016, bleeding problems with Pradaxa and similar anticoagulants were linked to more than 3,000 deaths last year. Most of those deaths were associated with Xarleto and Eliquis, which are the two most widely used novel oral anticoagulants, and do not have approved reversal agents available.

Pradaxa, Xarelto, Eliquis and other new-generation anticoagulants were released in recent years without a safe and effective reversal agent, leaving many doctors helpless to control or stop bleeding problems that develop among users. The drug makers have promoted the novel oral anticoagulants as superior alternatives to warfarin, which has been the go-to treatment for blood clots for decades among individuals with atrial fibrillation. However, the blood thinning effects of warfarin can be quickly reversed with a dose of vitamin K and fresh frozen plasma.

At one time, Boehringer Ingelheim faced more than 4,000 Pradaxa lawsuits brought on behalf of individuals nationwide who suffered severe and sometimes fatal bleeding problems, alleging that the drug maker failed to adequately warn consumers or the medical community about the serious bleeding risk or lack of a reversal agent.

Following several years of litigation, the drug maker reached Pradaxa settlements in 2014, agreeing to pay $650 million to resolve cases, with an average payment of about $150,000 per claim. However, the drug maker has continued to face new claims brought on behalf of individuals who have continued to experience bleeding problems due to the lack of an available Pradaxa antidote.

In recent years, as lawsuits over Pradaxa mounted, the competing new-generation drugs Xarelto and Eliquis have seen their sales increase. However, neither has an FDA approved reversal agent. More than 18,000 Xarelto lawsuits are currently pending against the makers of that drug, and a growing number of Eliquis lawsuits started to be filed over the past year.

Portolo Pharmaceuticals proposed a reversal agent for Xarelto and Eliquis in September 2016, but the FDA rejected it, calling for additional information on the manufacturing process, and data on whether it can be used with other Factor Xa inhibitors, like Savaysa.