Octapharma USA has submitted its Biological License Application (BLA) for octaplasLG® to the U.S. Food and Drug Administration (FDA) with the goal of expanding its U.S. product portfolio by the fourth quarter of 2012.
The FDA will evaluate the octaplasLG® BLA for an indication of managing preoperative or bleeding patients who require replacement of multiple plasma coagulation factors. The application also seeks to gain marketing approval for the substitution of intentionally removed plasma, such as plasma exchange in patients with thrombotic thrombocytopenic purpura (TTP), a blood disorder that causes clot formation in small blood vessels. The product features solvent/detergent inactivation against enveloped viruses and immune neutralization against non-enveloped viruses.
"We look forward to bringing octaplasLG® to the U.S. medical community," said Octapharma USA President Flemming Nielsen. "This trusted therapy has been successfully used to treat patients for more than 15 years in Europe and over 30 countries worldwide."
Octapharma USA has started to lay the groundwork for the introduction of octaplasLG®, coordinating a physician advisory board meeting in late 2011 with leading treatment professionals in transfusion medicine, hematology and surgery.
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