CSL Behring Submits Marketing Authorization Variation Application to European Medicines Agency (EMA) for Privigen® in Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Bern, Switzerland — 30 May 2012
CSL Behring announced today that it has submitted a Variation Application to the European Medicines Agency (EMA) for the use of Privigen® (immune globulin intravenous [human], 10 percent liquid for intravenous administration) in Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP). CIDP is a rare neurological disorder of the peripheral nerves characterized by symmetrical 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.
"The data contained in this application provide clinical evidence that Privigen is a safe, and efficacious option for CIDP patients in Europe who are managing this very challenging condition," said Russell Basser, M.D., Senior Vice President, Global Clinical R&D at CSL Behring. "If approved in Europe for use in treating CIDP, Privigen will represent a meaningful advance in many rare disease communities across the continent."
The CSL Behring European application 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 31 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 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 secondary endpoints, including objective measures of muscle strength of the hands at the completion visit. As seen in other intravenous immunoglobulin (IVIg) trials, headache was the most common adverse event in the PRIMA study.
Chronic Inflammatory Demyelinating Polyradiculoneuropathy (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.
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 Europe 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, and allogeneic haematopoietic stem cell transplantation (HSCT) in patients with secondary hypogammaglobulinemia.
For more information about Privigen, including full prescribing information, visit
http://www.privigen.com/Professional/Prescribing-Information.aspx and for Europe
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 indicated for the treatment of coagulation disorders including hemophilia and von Willebrand disease, primary immune deficiencies, hereditary angioedema and inherited respiratory disease. The company’s products are also used in cardiac surgery, organ transplantation, burn treatment and to prevent hemolytic disease of 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 information: