FDA Approves Demyelinating Polyneuropathy Treatment
Privigen has been approved by the FDA.
CSL Behring announced that the Food and Drug Administration (FDA) has approved Privigen (immune globulin intravenous [human] 10% liquid) for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP) to improve neuromuscular disability.
CIDP, a rare autoimmune condition, affects the peripheral nerves and can cause permanent nerve damage. The FDA approval was based on data from two Phase 3 studies, PATH and PRIMA. In PATH (n=207), 73% of patients were responsive to Privigen over 13 weeks, as measured by the adjusted score on the Inflammatory Neuropathy Cause and Treatment (INCAT) scale. In PRIMA (n=28), 61% of patients were responsive to Privigen over 25 weeks, as measured by their adjusted INCAT score.
Privigen is a ready-to-use liquid intravenous immune globulin product stabilized with proline. Proline has been shown to reduce IgG aggregation and dimer formation. Privigen is already approved to treat primary humoral immunodeficiency (PI) and chronic immune thrombocytopenic purpura (ITP) in patients aged ≥15 years.
Privigen is available as 0.1g/mL strength solution for intravenous infusion in 50mL, 100mL, 200mL, and 400mL vials.
CSL Behring announces FDA approval of Privigen® [immune globulin intravenous (human), 10% liquid] for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) in adults [press release]. King of Prussia, PA: CSL Behring; September 14, 2017.