FDA approves first-ever Pradaxa 'antidote,' BI's Praxbind
- Boehringer Ingelheim's Praxbind (idarucizumab), which is designed to reverse the effects of the company's popular anticoagulant Pradaxa (dabigatran), is a fully humanized antibody fragment (Fab).
- BI's Pradaxa was approved in 2010 to prevent stroke and systemic blood clots in patients with atrial fibrillation (AF), as well as those with deep vein thrombosis (DVT) and pulmonary embolism (PE).
- In clinical studies, all of the patients given Pradaxa and then given Praxbind experienced immediate reduction in the amount of Pradaxa in their blood. In a separate trial, 89% of patients who were experiencing uncontrolled bleeding or required immediate surgery had full reversal of the effects of Pradaxa within four hours of receiving Praxbind.
Praxbind, which is administered via injection, was approved under the FDA's accelerated approval program. It's been seven months since BI filed for approval of Praxbind, and there has been a sense of urgency associated with gaining approval.
The backstory: BI has dealt with reports of numerous Pradaxa-related deaths (roughly 280) and adverse events (roughly 1,400) in the last five years. Although not all of the adverse events were related to internal bleeding, many were. In addition , in 2014, BI settled a $650 million class action lawsuit last year related to bleeding episodes and their consquences.
Enter Praxbind, which could be considered the equivalent of vitamin K for warfarin. Having an antidote for Pradaxa will undoubtedly increase its therapeutic value—and most likely its use.