CSL Behring's Privigen has obtained marketing authorization from the European Commission for use in chronic inflammatory demyelinating polyneuropathy (CIDP).
Privigen is an immune globulin intravenous [human], 10% liquid, developed for intravenous administration in CIDP patients.
CSL Behring research and development senior vice president Val Romberg said it is critical to find new therapies against CIDP as it is a progressive disease that causes permanent nerve damage and impairs functional ability.
"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," Romberg added.
The approval is based on positive data from single-arm Privigen Impact on Mobility and Autonomy study that assessed Privigen's safety and efficacy in 28 CIDP patients.