HOBOKEN, N.J., Dec. 1, 2010 /PRNewswire/ -- 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 has 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 III, 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. For further information about this and other Octapharma clinical trials, please visit www.clinicaltrials.gov.
About the Octapharma Group
Headquartered in Lachen, Switzerland, Octapharma AG is one of the largest human protein products manufacturers in the world and has been committed to patient care and medical innovation for over 27 years. Octapharma's core business is the development, production and sale of high quality human protein therapies from both human plasma and human cell-lines, including immune globulin intravenous (IGIV). In the U.S., Octapharma's IGIV product, octagam® (immune globulin intravenous [human] 5%), is used to treat disorders of the immune system, and Octapharma's Albumin (Human)® is indicated for the restoration and maintenance of circulating blood volume. Octapharma's wilate® received orphan drug exclusivity from the U.S. Food and Drug Administration (FDA) for the treatment of von Willebrand disease (VWD). Octapharma employs over 4,000 people and has biopharmaceutical experience in 80 countries worldwide, including the United States, where Octapharma USA is located in Hoboken, N.J. Octapharma operates two state-of-the-art production sites licensed by the FDA, providing a high level of production flexibility. For more information, please visit www.octapharma.com.
This news release contains forward-looking statements, which include known and unknown risks, uncertainties and other factors not under the company's control. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. These factors include results of current or pending research and development activities and actions by the FDA or other regulatory authorities.
SOURCE Octapharma USA