U.S. FDA grants Breakthrough Therapy Designation to Pradaxa® (dabigatran etexilate) specific investigational antidote
Posted: 30 June 2014 | | No comments yet
The U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to the investigational antidote idarucizumab…
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to the investigational antidote idarucizumab* (a humanized antibody fragment), currently being studied as a specific antidote for the oral anticoagulant Pradaxa® (dabigatran etexilate).3
“In light of Boehringer Ingelheim’s core mission to provide value through innovation, we are pleased that the FDA has granted Breakthrough Therapy Designation to idarucizumab to help expedite its development,” said Professor Klaus Dugi, Chief Medical Officer, Boehringer Ingelheim. “It’s important to note that the positive efficacy and safety profile for Pradaxa® is well-documented in both clinical trials and real-world evaluations, which were all conducted in the absence of an antidote. The specific investigational antidote for Pradaxa®, which our scientists at Boehringer Ingelheim are developing, would give physicians an additional and highly targeted option beyond the already existing measures for treatment in case of certain emergency situations.”
The FDA established the Breakthrough Therapy Designation as a means to accelerate the development and review of drugs for serious or life-threatening conditions if preliminary clinical evidence indicates the therapy may demonstrate a substantial improvement over existing therapies on one or more clinically significant endpoints.4
Prior clinical research of the antidote in a healthy volunteer study with 145 participants has already demonstrated the potential of the antidote for immediate, complete and sustained reversal of the anticoagulant effect of dabigatran.1 In the placebo-controlled study, the antidote was well tolerated and did not cause any clinically relevant side effects.1 These aspects are especially valuable in clinical situations where rapid reversal of dabigatran-induced anticoagulation may be beneficial for patients taking Pradaxa®.
REVERSE-AD, a global patient study, is now underway to investigate the potential antidote in the clinical setting in patients taking Pradaxa® who have uncontrolled bleeding or require emergency procedures.3 The study will be open to eligible patients in more than 35 countries and at over 500 sites.3 This is the first time that an antidote under development for a novel oral anticoagulant is investigated in a study in patients.3
The antidote is still under investigation and has not yet been approved for clinical use.
- Glund S, et al. A specific antidote for dabigatran: immediate, complete and sustained reversal of dabigatran induced anticoagulation in healthy male volunteers. American Heart Association Scientific Sessions, Dallas, TX, USA, 16-20 November 2013, abstract 17765.
- Schiele F, et al. A specific antidote for dabigatran: functional and structural characterization. Blood. 2013;121:3554-62.
- Boehringer Ingelheim Data on File.
- U.S. Food and Drug Administration. Fact Sheet: Breakthrough Therapies. Available at: http://www.fda.gov/regulatoryinformation/legislation/federalfooddrugandcosmeticactfdcact/significantamendmentstothefdcact/fdasia/ucm329491.htm. Last Accessed: June 2014