Biotherapeutics company CSL Behring revealed on Friday the receipt of approval from the US Food and Drug Administration (FDA) for Hizentra (Immune Globulin Subcutaneous [Human] 20% Liquid) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP).

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. This may result in numbness or tingling, muscle weakness, fatigue and other symptoms.

The company said Hizentra (Immune Globulin Subcutaneous [Human] 20% Liquid) is the first and only subcutaneous immunoglobulin (SCIg) for the treatment and maintenance of chronic inflammatory demyelinating polyneuropathy (CIDP) to prevent relapse of neuromuscular disability and impairment.

This US FDA approval was based on data from the company's Phase III PATH (Polyneuropathy And Treatment with Hizentra) study, which is the largest controlled clinical study in CIDP patients to date. The percentage of patients experiencing CIDP relapse or withdrawal for any other reason during SCIg treatment was significantly lower with Hizentra than with placebo.

Hizentra (Immune Globulin Subcutaneous [Human] 20% Liquid), the world's most prescribed SCIg, has a proven track record of safety, efficacy and tolerability since 2010. Hizentra was developed for subcutaneous use is registered in over 51 countries for certain immune deficiencies, concluded the company.