, Feb. 27, 2012
/PRNewswire/ -- 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.
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 nearly 30 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 primary immune deficiencies, and Octapharma's Albumin (human)® is indicated for the restoration and maintenance of circulating blood volume. Octapharma's wilate® (Von Willebrand Factor/Coagulation Factor VIII Complex [human]) received orphan drug exclusivity from the U.S. Food and Drug Administration (FDA) for the treatment of certain types ofVon 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 or www.wilateusa.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