Boehringer seeks real-world data to support reversal agent
- In October 2015, the FDA approved Boehringer Ingelheim's Praxbind (idarucizumab), the specific reversal agent for Pradaxa (dabigatran). Now Boehringer is initiating the RE-VECTO program to collect and analyze data on how Praxbind is being used in real-world situations, according to the company.
- The RE-VECTO Surveillance program will collect data on how Praxbind is used in various clinical settings. The goal is to capture data about the hospital pharmacy that dispenses Praxbind, as well as why reversal was needed and the patient's profile. At least 300 patients will be included in the analysis.The study is expected to be complete by the end of 2018.
- This real-world data builds on data from Phase 3 REVERSE-AD trial, which showed that Praxbind rapidly and completely reversed the anticoagulant activity of Pradaxa in 88 to 98% of patients.
Data from RE-VECTO will be an important addition to the overall evidence base for Praxbind, building on the data captured from REVERSE-AD.
The REVERSE-AD analysis was an 'all-comer' study that included patients who needed to reverse Pradaxa treatment because of their need to undergo an emergency procedure. For example, in one case a patient required emergency surgery after sustaining injuries in a car accident, and in another a patient experienced an open fracture, which required surgery.
The program is a global, multi-center surveillance program that is available to all hospital pharmacies where Praxbind is being used. It is intended to collect anonymous data on dispensing and usage patterns of the reversal agent in a clinical practice setting, Sabine Luik, SVP of Medicine & Regulatory Affairs, at Boehringer, said in an email to BioPharma Dive.
Additional real-world data from the RE-VECTO Surveillance program will help fulfill Boehringer's post-marketing requirements by collecting data about Pradaxa from different settings and in different patients. The program will allow the company to assess whether both the drug and the reversal agent are being used the same way they were in clinical trials.
"Every emergency situation is unique. We believe that the data we collect will help us better understand how, and in which situations, Praxbind is being used in clinical practice. Ultimately, this information may help us provide healthcare practitioners and patients with relevant information about anticoagulation reversal when making treatment decisions. For payers, this data may provide additional insights on stocking and formulary decision-making," said Luik.
Pradaxa is one of several new oral anticoagulants that has hit the market since 2010, meant to replace warfarin. While all of the new drugs have more favorable dosing and safety profiles, they have been struggling to gain market share. The high-priced alternatives are still not being used as often as the generically-available standard-of-care. Boehringer is hoping that having a reversal agent specifically designed for use with Pradaxa will help bolster sales.
Portola Pharmaceuticals is currently awaiting approval of its own anticoagulant reversal agent that has been tested with competing oral anticoagulants Xarelto and Eliquis.
- Boehringer Ingelheim Statement