CSL's Hizentra gains approvals for rare disease CIDP

CSL Ltd. (ASX:CSL) subsidiary CSL Behring said FDA and the European Commission have each approved Hizentra human immune globulin as a maintenance treatment to prevent relapse of neuromuscular disability and impairment in patients with chronic inflammatory demyelinating polyneuropathy (CIDP), an autoimmune disorder that affects peripheral nerves.

The company said Hizentra is the first subcutaneous immunoglobulin formulation approved as a maintenance therapy for CIDP. It announced FDA's approval Friday and the EU approval on Thursday.

Hizentra is a 20% formulation of subcutaneous IgG. CSL Behring also markets Privigen, a 10% formulation of IV IgG, to treat CIDP.

Hizentra is also marketed as a replacement therapy in patients with immunodeficiencies.