FDA OKs First Subcutaneous Immune Globulin
New, at-home delivery option for patients with primary immune deficiency diseases
TUESDAY, Jan. 10 (HealthDay News) -- The U.S. Food and Drug Administration has approved the first subcutaneous immune globulin replacement therapy for use in patients with primary immune deficiency diseases (PIDD). Vivaglobin is made by ZLB Behring GmbH of Marburg, Germany, from human plasma gathered at licensed U.S. plasma centers, according to an FDA statement. The drug is injected weekly under the skin using an infusion pump, allowing patients to administer it to themselves at home.
About 50,000 people in the United States have inherited PIDD disorders that require regular immune globulin treatment to avoid infections. Subcutaneous delivery gives patients who cannot tolerate chronic intravenous injections a safe alternative, according to the FDA statement.
"This is an important approval for patients who need lifesaving immune globulin products," Jesse Goodman, M.D., director of the FDA's Center for Biologics Evaluation and Research, said in the FDA statement. "This new product provides a unique new treatment delivery option to patients and their physicians."
Paul Perreault, ZLB Behring's executive vice president of Worldwide Commercial Operations, said in a statement that the FDA approval is a "milestone achievement" that will help thousands of PIDD patients.