CSL Behring ’s Privigen Now Approved to Treat CIDP

The U.S. Food and Drug Administration (FDA) has approved Privigen (immune globulin intravenous [human] 10% liquid) to treat adults with chronic inflammatory demyelinating polyneuropathy (CIDP) to improve neuromuscular disability. Approval is based on two Phase III studies: Polyneuropathy and Treatment with Hizentra (PATH) and Privigen Impact on Mobility and Autonomy (PRIMA). In the PATH study, 73 percent of 207 CIDP patients receiving Privigen (as placebo) responded to treatment as measured by their adjusted score on the Inflammatory Neuropathy Cause and Treatment scale. In the PRIMA study, 61 percent of 28 patients responded to treatment.

“It is a priority in the care of CIDP patients to provide therapies that improve and maintain their strength and function while at the same time preventing relapses and minimizing side effects. However, current treatments do not work for all CIDP patients,” said Mazen M. Dimachkie, professor and director of the neuromuscular division, executive vice chairman in the department of neurology at the University of Kansas Medical Center, and an investigator in the PATH study. “Privigen’s approval by the FDA for the treatment of CIDP means that people with CIDP and their treating physicians have gained another treatment option that is safe and effective in helping improve strength and motor function, while potentially delaying disease relapse.”