Boehringer Ingelheim files BLA for antidote to dabigatran

Boehringer Ingelheim announced that it has submitted a biologics license application to the FDA requesting an accelerated approval pathway for idarucizumab, an antidote to dabigatran.

In June 2014, the investigational reversal agent received a breakthrough therapy designation from the FDA.

Idarucizumab, a humanized antibody fragment, has been shown in preclinical studies to bind to and inhibit dabigatran (Pradaxa, Boehringer Ingelheim). It is being evaluated in the RE-VERSE AD phase 3 clinical study of patients treated with dabigatran who are in need of emergency intervention or who experience an uncontrolled or life-threatening bleeding event, according to the release.

The submission includes phase 1, placebo-controlled data that demonstrate idarucizumab provided immediate, complete and sustained reversal of dabigatran’s anticoagulant effect in healthy volunteers, and was not associated with any clinically relevant adverse events, according to the release.

Source: www.healio.com