Boehringer Ingelheim Receives FDA Breakthrough Therapy Designation for Idarucizumab

Boehringer Ingelheim reports that the US 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).

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.

The antidote is still under investigation and has not yet been approved for clinical use.

Source: Boehringer Ingelheim


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