Physicians' Academy for Cardiovascular Education

FDA Fast Track designation for investigational anticoagulant reversal agent

News - Apr. 7, 2015

The U.S. Food and Drug Administration (FDA) granted a Fast Track designation to the investigational anticoagulant reversal agent PER977, developed by Perosphere.
PER977 is a small synthetic water-soluble new molecular entity that directly combines with the NOACs, fondaparinux, low molecular weight heparins and unfractionated heparins allowing rapid re-establishment of a normal blood coagulation state. This reversal effect is due to direct binding to the anticoagulant molecule with no binding to blood coagulation factors or to other proteins in the blood.
Currently, there is no approved reversal agent for the NOACs.
 
The Fast Track designation process has been established to facilitate the development and expedite the review of drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.
PER977 is undergoing clinical development as a sterile, intravenous injection. The company is currently preparing for Phase 3 trials.
 

For more information:

www.perosphere.com