The FDA on March 16 approved CSL Behring's drug Hizentra to treat chronic inflammatory demyelinating polyneuropathy.
Hizentra is the first subcutaneous immunoglobulin approved to treat CIDP, a rare autoimmune disorder that affects the peripheral nerves.
The drug is intended for use as a maintenance therapy to prevent a relapse of neuromuscular disability and impairment associated with the disease.
"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 GBS|CIDP Foundation International, a nonprofit advocacy group for patients with CIDP and Guillain-Barré syndrome.