Subcutaneous Immune Globulin Approved for Treatment of Patients With Chronic Inflammatory Demyelinating Polyneuropathy
Already approved in 51 countries for some immune deficiencies, subcutaneous immune globulin (IG) (Hizentra; King of Prussia, PA) has now been approved by the Food and Drug Administration (FDA) for treating patients with chronic inflammatory demyelinating polyneuropathy (CIDP). Approval was based on data from the phase 3 polyneuropathy and treatment with hizentra (PATH) clinical trial, the largest controlled clinical study in CIDP patients performed to date.
Findings from PATH showed that 38.6% of patients treated with 0.2 g/kg of subcutaneous IG had a relapse vs 63.2% of patients treated with placebo (P = .007). Only 2.7% of patients treated with subcutaneous IG had systemic adverse reactions, a significantly lower rate than the 9.8% seen in patients treated with intravenous IG (IVIG). Of note, 3,957 of 4,225 (93%) total subcutaneous IG infusions had no adverse reactions.
"As a practicing neurologist treating patients with CIDP, I am excited to have a safe and effective subcutaneous treatment option to offer my patients who are interested in more treatment flexibility and control in their busy lives," said Dr. Todd Levine, Phoenix Neurological Associates.
"Despite available treatment options, many CIDP patients continue to struggle with daily disease and lifestyle challenges, making continued research and innovation critical," said Lisa Butler, executive director of the GBS|CIDP Foundation International. "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."