Pradaxa faces challenges in U.S., moves forward in EU with approval
- Pradaxa (dabigatran etexilate) has been approved in the EU for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE)
- Boehringer Ingelheim (BI) recently settled 4,000 lawsuits in the US due to drug-related bleeding events
- BI recently presented data at the American College of Cardiology (ACC) meeting on a preclinical therapy being developed to reverse Pradaxa-induced excess bleeding.
Approval of Pradaxa in the U.S. and the EU was based on very compelling phase 3 trials, including preliminary efficacy data that showed a 92% reduction in the risk of recurrent blood clots in Pradaxa-treated patients, versus placebo, Overall, phase 3 clinical trials showed comparable efficacy to warfarin, which has long been the standard of care for anticoagulation therapy, and better safety. Nonetheless, there have been numerous incidents of fatal bleeding in patients treated with Pradaxa, leading to over 4,000 state and federal lawsuits, which BI settled recently.
Regulators have conducted a risk/benefit analysis and decided that Pradaxa is a suitable antocoagulation treatment, especially considering the fact that PE due to DVT is still the leading cause of preventable death in hospitals. In fact, almost a third of PE patients die within the first three months after the event.
Pradaxa is part of a new class of anticoagulation treatments that also includes Xarelto (rivoroxaban) and Eliquis (apixaban) that have been established as a viable alternative to warfarin. Pradaxa also has the advantage of being a fixed-dose drug. Nonetheless, warfarin can be reversed with vitamin K, but the newer classes of anticoagulants do not have such a simple fix. BI, however, is working to develop a remedy for over-bleeding in Pradaxa-treated patients. Once that happens, this new-generation anticoagulant will be even more appealing to clinicians and patients alike.