The U.S. Food and Drug Administration (FDA) has approved Octapharma USA’s Investigational New Drug Application for octaplex (Human Prothrombin Complex, Freeze Dried) 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 also previously granted orphan drug exclusivity for octaplex in this indication.
“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,” said Octapharma USA President Flemming Nielsen. “Surgical procedures in patients receiving anticoagulant therapy could lead to serious bleedings that, if left untreated, could lead to increased mortality. Oral anticoagulation not only increases the risk for spontaneous bleedings, but also increases the associated morbidity and mortality rates.”
Octapharma USA is a subsidiary of Octapharma AG, one of the largest human protein products manufacturers in the world. The biopharmaceutical company is currently enrolling patients in PROTECT, a Phase 3, prospective randomized, open-label, multicenter clinical trial designed to demonstrate the efficacy and safety of octaplex compared to fresh frozen plasma (FFP). Octaplex is a double virus-inactivated concentrate with a balanced level of Vitamin K-dependent coagulation factors and protein C and S.
Date: December 1, 2010
Source: Octapharma USA
