Biotherapeutics comany CSL Behring disclosed on Thursday the receipt of US Food and Drug Administration's (FDA) approval for Privigen [Immune Globulin Intravenous (Human), 10% Liquid] for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP) to improve neuromuscular disability.
CIDP is a rare autoimmune disorder that affects the peripheral nerves (those outside the brain and spinal cord), the myelin sheath, the protective covering of the nerves, is damaged. It effects can worsen over time and approximately 30% of the patients will progress to wheelchair dependence if not treated.
The company said Privigen is the first and only 10 percent, ready to use, room-temperature stored, liquid IVIG stabilized with proline. A naturally occurring amino acid, proline has been shown to reduce IgG aggregation and dimer formation. It is available in over 70 countries around the world for treating these and other rare diseases.
This US FDA approval was based on results from the company's two Phase III clinical studies: the PATH study and the PRIMA study.
In PATH study, which the largest controlled clinical study in CIDP patients to date, about 73% responded to Privigen over the course of treatment, as measured by their adjusted score on the Inflammatory Neuropathy Cause and Treatment (INCAT) scale.
Under the company's PRIMA (Privigen Impact on Mobility and Autonomy) study, 61% of patients responded to Privigen over 25 weeks, as measured by their adjusted INCAT score.
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