CSL Ltd. said the U.S. Food and Drug Administration approved its second autoimmune disorder medicine.
Australia-based CSL's Hizentra will be used to treat chronic inflammatory demyelinating polyneuropathy, a rare autoimmune disorder that targets the peripheral nerves and may cause permanent nerve damage.
Hizentra will be used as maintenance therapy to prevent relapse of neuromuscular disability and impairment.
"The approval of Hizentra offers patients who were once burdened by traveling to the infusion center or hospital the flexibility to self-administer their treatment at a time, place, and on a schedule that's convenient for them," said Lisa Butler, executive director of the nonprofit GBS|CIDP Foundation International, in a statement.
The U.S. FDA previously approved CSL's Privigen for the same indication.
Hizentra is approved in 51 countries for treating certain immune deficiencies.
