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FDA OKs Drug for Rare Immune Condition
Jan. 13, 2005 - A new type of drug may help prevent serious infections in people with a rare immune condition that makes them prone to infection and unable to withstand other types of preventive treatment.
The FDA has approved the first immune globulin product that's delivered under the skin for use in people with primary immune deficiency diseases (PIDD), a hereditary condition that affects about 50,000 people in the U.S.
The drug, Vivaglobin, is manufactured from human plasma collected at licensed U.S. plasma centers. It's delivered under the skin on a weekly basis using an infusion pump, which means patients can treat themselves at home.
Alternative Delivery Method
Researchers say some people with PIDD have problems that can make using intravenous drugs (delivery of medication into the vein) difficult; Vivaglobin may offer a valuable alternative.
"This is an important approval for patients who need lifesaving immune globulin products," says Jesse Goodman, MD, MPH, director of FDA's Center for Biologics Evaluation and Research, in a news release. "This new product provides a unique new treatment delivery option to patients and their physicians."
The FDA says clinical studies show Vivaglobin is well-tolerated. The most common side effects were mild or moderate reactions at the injection site, including swelling, redness, and itching.
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