CSL Behring announced today that the European Commission has granted marketing authorization for the use of Privigen® (immune globulin intravenous [human], 10 percent liquid, for intravenous administration) in the treatment of patients with chronic inflammatory demyelinating polyneuropathy (CIDP). CIDP is a rare neurological disorder of the peripheral nerves characterized by weakness in the arms and legs that progressively worsens for longer than two months. CSL Behring is a subsidiary of CSL Limited (ASX:CSL), a biopharmaceutical company headquartered in Melbourne, Australia.
“CIDP is a progressive disease that may cause permanent nerve damage and impair functional ability, and finding new therapies to slow the advance of this illness is critical,” said Val Romberg, Senior Vice President, Research and Development for CSL Behring. “CSL Behring is pleased to continue its leadership in the development of innovative Ig therapies by providing Privigen to address the treatment needs of patients with this rare disorder.”
The European approval is based on results of the PRIMA study (Privigen Impact on Mobility and Autonomy), a single-arm study designed to evaluate the safety and efficacy of Privigen in 28 patients who have CIDP. In PRIMA, patients on Privigen had a clinically meaningful improvement in their disease by demonstrating a statistically significant change in their INCAT (Inflammatory Neuropathy Cause and Treatment) score at the completion visit—the primary endpoint, which was met. Overall, 61 percent of patients responded to Privigen and of those patients who responded to Privigen in the PRIMA study, 50 percent did so within four weeks of being treated in the study. Privigen also demonstrated improvements on the functional assessments of grip strength in both hands and motor impairment at the completion visit. As seen in other intravenous immunoglobulin (IVIg) trials, headache was the most common adverse event in the PRIMA study.
About Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
CIDP is a rare disorder of the peripheral nerves characterized by symmetrical weakness in the arms and legs that progressively worsens for longer than two months. CIDP is believed to be underdiagnosed and undertreated. Therefore, its prevalence is difficult to determine, with some estimates being as high as 8.9 per 100,000 adults. If left untreated, approximately 30 percent of CIDP patients will progress to wheelchair dependence. CIDP can occur at any age; typically, initial onset occurs between the ages of 30 and 60. Early recognition and treatment can help prevent disability and improve recovery from CIDP.
About Privigen
Privigen is part of the immunoglobulin (Ig) franchise of CSL Behring. CSL Behring manufactures Privigen at its state-of-the art facility in Bern, Switzerland where the most advanced technologies are applied to ensure product safety and supply. This facility represents the long-term commitment of CSL Behring to global Ig markets.
Privigen is the first and only 10 percent liquid IVIg stabilized with proline, a naturally occurring amino-acid. In the EU it is indicated for treating: primary immunodeficiency, primary immune thrombocytopenic purpura, Guillain-Barré syndrome, Kawasaki disease, replacement therapy in multiple myeloma or chronic lymphocytic leukemia with secondary hypogammaglobulinemia and recurrent infections, replacement therapy in children with congenital AIDS and recurrent infections, allogeneic haematopoietic stem cell transplantation (HSCT) in patients with secondary hypogammaglobulinemia, and chronic inflammatory demyelinating polyneuropathy. For more information about Privigen, including full prescribing information for the USA, visit http://www.privigen.com/Professional/Prescribing-Information.aspx and for Europe http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000831/human_med_000993.jsp&jsenabled=true.
About CSL Behring
CSL Behring is a leader in the plasma protein therapeutics industry. Committed to saving lives and improving the quality of life for people with rare and serious diseases, the company manufactures and markets a range of plasma-derived and recombinant therapies worldwide.
CSL Behring therapies are used around the world to treat coagulation disorders including hemophilia and von Willebrand disease, primary immune deficiencies, hereditary angioedema and inherited respiratory disease, and neurological disorders in certain markets. The company’s products are also used in cardiac surgery, organ transplantation, burn treatment and to prevent hemolytic diseases in the newborn. CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. CSL Behring is a subsidiary of CSL Limited (ASX:CSL), a biopharmaceutical company headquartered in Melbourne, Australia. For more information, visit www.cslbehring.com.
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Media Contacts:
Sheila A. Burke, Director, Communications & Public Relations
Worldwide Commercial Operations CSL Behring
O: 610-878-4209
Sheila Burke at cslbehring.com