HOBOKEN, N.J., May 13 /PRNewswire/ -- Octapharma USA today announced that wilate®, the first replacement therapy development specifically for von Willebrand Disease (VWD), is now available from the biopharmaceutical company's authorized distributors. The U.S. Food and Drug Administration (FDA) has approved wilate® for the treatment of spontaneous or trauma-induced bleeding episodes in patients with severe VWD as well as in patients with mild or moderate forms of the illness in whom the use of desmopressin is known or suspected to be ineffective or contraindicated.
"Wilate® is an innovative treatment option for patients with von Willebrand disease that offers a high purity VWF/FVIII complex with a physiologic ratio of FVIII and VWF, double virus inactivation, convenient dosing, and clinical efficacy, safety, and tolerability proven in adult and pediatric populations," said Flemming Nielsen, President of Octapharma USA, the rapidly growing U.S. division of Octapharma AG, one of the largest plasma products manufacturers in the world. "We are pleased to be partnering with distributors who are committed to providing medical professionals with the therapies patients need in a timely, cost-effective manner."
According to the National Institutes of Health (NIH), VWD is the most common inherited bleeding disorder and occurs in about 1 out of every 100 to 1,000 people.
About the Octapharma Group
Headquartered in Lachen, Switzerland, Octapharma is one of the largest plasma products manufacturers in the world and has been committed to patient care and medical innovation for over 25 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® was approved by the U.S. Food and Drug Administration (FDA) for the treatment of von Willebrand disease (VWD). Octapharma employs over 3,000 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.
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