FDA News

FDA grants priority review status for idarucizumab

Boehringer Ingelheim Pharmaceuticals Inc. announced that the FDA has granted priority review status for the company’s biologics license application for idarucizumab as a reversal agent for the novel oral anticoagulant dabigatran, according to a company press release.

The company is investigating idarucizumab among patients who require emergency intervention or experience uncontrolled or life-threatening bleeding while on dabigatran (Pradaxa, Boehringer Ingelheim). There are currently no approved reversal agents for novel oral anticoagulants; idarucizumab is the first specifically targeted reversal agent to be under priority review, according to the release.

The biologics license application for idarucizumab follows data from three phase 1 trials indicating that the drug causes immediate reversal of the effects of dabigatran, with no incidence of clinically relevant adverse events related to treatment and no procoagulant effects. The application also included interim data from RE-VERSE AD, an ongoing, international phase 3 trial evaluating idarucizumab in clinical settings.

“If approved, idarucizumab has the potential to be a significant evolution in care by providing physicians with an option for Pradaxa patients in rare emergency situations that may require rapid reversal of the anticoagulation effect of dabigatran,” Sabine Luik, MD, senior vice president of medicine and regulatory affairs at Boehringer Ingelheim, said in the release.

Boehringer Ingelheim Pharmaceuticals Inc. announced that the FDA has granted priority review status for the company’s biologics license application for idarucizumab as a reversal agent for the novel oral anticoagulant dabigatran, according to a company press release.

The company is investigating idarucizumab among patients who require emergency intervention or experience uncontrolled or life-threatening bleeding while on dabigatran (Pradaxa, Boehringer Ingelheim). There are currently no approved reversal agents for novel oral anticoagulants; idarucizumab is the first specifically targeted reversal agent to be under priority review, according to the release.

The biologics license application for idarucizumab follows data from three phase 1 trials indicating that the drug causes immediate reversal of the effects of dabigatran, with no incidence of clinically relevant adverse events related to treatment and no procoagulant effects. The application also included interim data from RE-VERSE AD, an ongoing, international phase 3 trial evaluating idarucizumab in clinical settings.

“If approved, idarucizumab has the potential to be a significant evolution in care by providing physicians with an option for Pradaxa patients in rare emergency situations that may require rapid reversal of the anticoagulation effect of dabigatran,” Sabine Luik, MD, senior vice president of medicine and regulatory affairs at Boehringer Ingelheim, said in the release.