The FDA has approved an investigational new drug application for octaplex (Octapharma USA), as a fast track product for "reversal of anticoagulation therapy in patients under vitamin K antagonist therapy with the need for urgent surgery or invasive procedures." The FDA had previously granted orphan drug exclusivity for octaplex in this indication.
"Surgical procedures in patients receiving anticoagulant therapy could lead to serious bleeding that, if left untreated, could lead to increased mortality," said Flemming Nielsen, president of Octapharma USA. "Octaplex has the potential to treat the serious condition defined as oral anticoagulation reversal in cases of urgent surgery where severe bleeding will become an issue."
The Lachen, Switzerland-based company is currently enrolling patients in PROTECT, a Phase III, prospective randomized, open-label, multicenter clinical trial designed to demonstrate the efficacy and safety of octaplex (human prothrombin complex, freeze dried) compared to fresh frozen plasma. Octaplex is a double virus-inactivated concentrate with a balanced level of vitamin K-dependent coagulation factors and protein C and S.