, Nov. 30, 2011
/PRNewswire/ -- Octapharma USA
announced that octagam®
[Immune Globulin Intravenous (human) 5% Liquid Preparation] is again available for purchase. The U.S. Food and Drug Administration
(FDA) on Nov. 3
approved the U.S. market return of octagam® 5%
, a therapy to treat disorders of the immune system.
In August 2010, Octapharma initiated a voluntary market withdrawal of octagam® 5% in the U.S. in response to an observed increase in thromboembolic events (TEEs), which occur when a clot or thrombus forms locally in a blood vessel or breaks loose in the blood stream to occlude another vessel. Octapharma has reported that global sales totaled 1.7 million grams of octagam® 5% and octagam® 10%, [Immune Globulin Intravenous (Human) Liquid Preparation] in the period January 1 through October 30, 2011, an estimated 60,000 treatments, during which there were no reports of TEEs.
"It is a very exciting time for patients throughout the U.S. as they again have access to octagam® 5%, a therapy that has long been valued by the medical community for patient tolerability," said Octapharma USA President Flemming Nielsen. "We have seen over the last year that there are industry-wide concerns over TEEs connected with multiple immune globulin products that remained on the market while we have implemented enhanced safety measures for octagam® 5%. Industry-wide, immune globulin products can lead to TEEs in approximately 1 individual or less for every 10,000 treatments. But our 10-month analysis of octagam® in nearly 60,000 treatments internationally showed that octagam® outperformed this industry benchmark with no reported TEEs."
Octapharma's estimate of 60,000 octagam® 5% and octagam® 10% patient treatments is based on reported global sales of 1.7 million grams, not on actual recorded patient treatment sessions. The number of treatments is based on average patient utilization per treatment. The data has not been submitted to the FDA for evaluation.
The FDA approval to return octagam® 5% to the U.S. market was based on changes Octapharma has made in the manufacturing process and the company's decision to implement a quality control test on every batch of product that is released to the marketplace for the absence of thrombogenic potential. Additionally, Octapharma will implement post-marketing studies to ensure product safety.
Earlier this year, multiple international regulatory agencies authorized the return of octagam® 5% and octagam® 10% in important worldwide markets. The product is presently approved for distribution in the U.S., Austria, Belgium, Bulgaria, Bosnia, Cyprus, Germany, Denmark, Estonia, Spain, Finland, France, Hungary, Iceland, Italy, Lithuania, Luxembourg, Latvia, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Sweden, Slovenia, Slovakia and the United Kingdom. octagam® 10% is not approved for marketing in the U.S.
For a list of preferred U.S. distributors for octagam® 5%, please visit www.octapharma.us.
About octagam® 5%
Immune Globulin Intravenous (Human), octagam® 5% liquid, is a solvent/detergent (S/D)-treated, sterile preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. octagam® 5% liquid is a solution for infusion which must be administered intravenously.
octagam® is an immune globulin intravenous (human) 5% liquid indicated for treatment of primary humoral immunodeficiency (PI), such as congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome and severe combined immunodeficiencies.
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 28 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