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FDA Breakthrough Therapy Designation: Boehringer Ingelheim Gets #44

June 28, 2014

Boehringer Ingelheim (BI) announces on June 26th, that the company’s investigational fully humanized antibody fragment (Fab), Idarucizumab, is granted FDA’s coveted Breakthrough Therapy Designation (BTD). The BTD is for Idarucizumab, being investigated to reverse the anticoagulant effect of Pradaxa (Dabigatran Etexilate Mesylate) – an antidote for Pradaxa. BI plans on pursuing an Accelerated Approval for Idarucizumab.

Pre-clinical studies indicate Idarucizumab binds specifically to and inhibits Dabigatran with no other expected interactions. Idarucizumab is being studied as an option for patients who “ … experience uncontrolled bleeding or need to undergo emergency surgery or another invasive procedure.” Currently, no specific antidotes for newer oral anticoagulants (NOACs) are available.

This is the 44th BTD announced by a sponsor company and the 2nd BTD for BI:

Num Drug Name Sponsor Company Indication
1 Volasertib BoehringerIngelheim Acute MyeloidLeukemia(AML)
2 Idarucizumab Boehringer Ingelheim Antidote for Pradaxa

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Please Note: “Kalymnos 2005 022” by David Bolius [CC By-SA 2.5] | Wikimedia Commons.

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