Pradaxa Reversal Agent Gets Positive Review From European Regulators

As the makers of all new-generation anticoagulants rush to identify a potential reversal agent to make their drugs safer, it appears that Pradaxa may be the first to have an antidote that doctors can use to stop severe bleeding problems that may develop among users.

Late last month, the European Medicines Agency (EMA) recommended approval of what is being called Praxbind (idarucizumab), which is an reversal agent for Pradaxa bleeding, designed to quickly counteract the blood thinning effects of the Boehringer Ingelheim drug in case of an emergency.

Boehringer Ingelheim announced the recommendations in a press release issued on September 25, indicating that the recommendation came after the EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on the proposed drug.

The drug maker indicates that CHMP reviewed a number of clinical drug trials designed to see if Praxbind could quickly and effectively stop bleeding events linked to the use of Pradaxa, which have resulted in thousands of adverse event reports since the drug hit the market a few years ago.

Pradaxa is part of a new-generation of blood thinners introduced in recent years as a replacement for warfarin, or Coumadin. Known as novel oral anticoagulants, other similar medications are marketed under the brand names Xarelto and Eliquis.

While the medications have been promoted as superior alternatives to warfarin for prevention of blood clots among patients with atrial fibrillation, and following hip and knee replacement surgery for at-risk populations, the medications have been linked to a large number of reported bleeding problems, where doctors were unable to control hemorrhages, often resulting in serious injury or death.

Although all blood thinners carry a risk of bleeding events, users of warfarin can be given a dose of vitamin K to reduce the blood-thinning effects. However, there have been no such reversal agents available for Pradaxa, Xarelto or Eliquis.

As sales for the new generation drugs have increased, manufacturers of Pradaxa, Xarelto and Eliquis have been racing to become the first to obtain approval for a safe and effective reversal agent, which may give their product a clear market advantage.

It is unclear when or if Praxbind will receive final approval in Europe or in the United States, but it appears to be on track to give Pradaxa a sales boost.

Although Pradaxa was the first to hit the market, it has become the weakest selling for the three drugs. Xarelto currently dominates the novel oral anticoagulant market, with Eliquis ranking second.

More than 4,000 Pradaxa lawsuits have been filed by users of that drug who suffered bleeding injuries. Following several years of litigation, Boehringer Ingelheim ultimately agreed to pay $650 million in Pradaxa settlements last year, with an average of about $150,000 per claim. However, the drug maker continues to face new Pradaxa claims brought by individuals who have experienced bleeding problems since the settlement.

A growing number of Xarelto lawsuits and Eliquis lawsuits are also being filed throughout the U.S., raising nearly identical allegations.