FDA grants accelerated approval to Boehringer Ingelheim’s drug

The US Food and Drug Administration (FDA) have given its approval to Praxbind, and now it can be used in patients with irregular heartbeats or atrial fibrillation.

The treatment, to be sold as Praxbind, is an antibody fragment created to reverse the anticoagulant effects of Pradaxa, which prevents clotting by blocking the enzyme thrombin.

“The anticoagulant effects of Pradaxa are important and lifesaving for a few patients, but there are situations where reversal of the drug’s effects is medically necessary”, Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products at the FDA’s Center for Drug Evaluation and Research, said in an FDA news release.

As blood thinners, Pradaxa, Xarelto and Eliquis are all meant to be more convenient alternatives to warfarin, an oral anti-coagulant that has been sold for more than 60 years but which comes with serious bleeding risks, hard dietary restrictions and the need for routine blood monitoring.

Having the ability to reverse anticoagulation in either critically bleeding patients or in patients who require urgent surgery can help both patients and treating physicians working with those patients, Sabine Luik, Boehringer’s senior vice president of medicine and regulatory affairs, told BioWorld Today.

Among the major charges made by POGO is that FDA knowingly approved Pradaxa without a way to stop patients from bleeding if they started to hemorrhage, as, unlike warfarin, Pradaxa has no reversal agent.

-The FDA approved Pradaxa on the basis of a single clinical trial.

In a new investigation, the watchdog group Project on Government Oversight (POGO) says that FDA was too “permissive” in its review of the anticoagulant dabigatran (Pradaxa-Boehringer Ingelheim).

In 2014, Boehringer agreed to pay $650 million to settle roughly 4,000 claims alleging that the company did not warn the public about the risks of uncontrolled bleeding with Pradaxa. Boehringer Ingelheim Pharmaceuticals’ drug Praxbind received accelerated approval. Perosphere, another Danbury-based pharmaceutical company, also has an antidote for Pradaxa that is still in the trial stage.

-Although Pradaxa can cause fatal bleeding – dangers acknowledged in the fine print of the product’s package insert – the FDA has not required the drug to carry a more conspicuous “black box” warning about those hazards.

She said the FDA stands by Pradaxa for the vast majority of patients, providing “an important health benefit when used as directed”. Researchers knew which subjects were taking the experimental drug, and, according to a key FDA reviewer, handled them differently.