Data from Pharmawand - Curated by EPG Health - Date added 03 March 2015

Boehringer has submitted a biologics license application (BLA) to the FDA requesting an Accelerated Approval pathway, for the use of BI 655075 (idarucizumab) to reverse the anticoagulant effect of dabigatran, the active ingredient in Pradaxa (dabigatran etexilate mesylate). The new application includes phase I data in volunteers showing that idarucizumab provided immediate, complete and sustained reversal of the anticoagulant effect of dabigatran.

In these placebo-controlled studies, idarucizumab did not cause any clinically relevant side effects. No pro-thrombotic effect was observed after the administration of idarucizumab and no return of anticoagulant activity of dabigatran was seen over time at adequate doses. Other phase I data in healthy volunteers show that idarucizumab restores wound-site formation of fibrin, the main component of a blood clot.

Comment: Boehringer is continuing to evaluate idarucizumab in RE-VERSE AD, a phase III global study investigating idarucizumab in actual clinical settings. This is the only trial to examine patients being treated with Pradaxa who are in need of emergency intervention or experience an uncontrolled or life-threatening bleeding event.

Comments

You will need to login, to leave a comment.

epgonline.org is not monitored for collection of adverse event reports. Any adverse events should be reported to your national reporting agency and/or the manufacturer.

Learning Zones

An epgonline.org Learning Zone (LZ) is an area of the site dedicated to providing detailed self-directed medical education about a disease, condition or procedure.

Cardiovascular Metabolism Knowledge Centre

Cardiovascular Metabolism Knowledge Centre

The Cardiovascular Metabolism Knowledge Centre is an information hub providing expert insight into the management of hypertension and type 2 diabetes. This Knowledge Centre contains a wealth of scientific video content offering insights and opinion from some of the leading experts in the field.

ESICM LIVES Highlights

ESICM LIVES Highlights

ESICM LIVES Congress 2018: Bringing you the latest news and insights from the 31st ESICM LIVES Congress, 20–24 October 2018 Paris, France.

Fluid Management

Fluid Management

Are you up-to-date with the latest evidence of effective procedures for fluid management?

+ 2 more

Load more

Related Content