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Date: Friday, Jan. 19, 1996 FOR IMMEDIATE RELEASE Contact:Lenore Gelb(301)443-3285
The Food and Drug Administration today announced licensing of the first product to protect high-risk infants against the worst effects of respiratory syncytial virus (RSV) disease, the most common cause of lower respiratory infections in children.
This FDA approval allows the marketing of Respiratory Syncytial Virus Immune Globulin Intravenous (Human) (RSVIGIV) for use in high-risk infants under two years old with lung problems due to chronic bronchopulmonary dysplasia (BPD) or prematurity.
RSVIGIV is manufactured by Massachusetts Public Health Biologic Laboratories of Boston, and distributed by MedImmune Inc. of Gaithersburg, Md., under the trade name RespiGam.
RespiGam has been found safe and effective in reducing the number and length of hospitalizations due to RSV as well as the severity of the disease in high risk infants.
"While this new drug does not prevent infections by respiratory syncytial virus, it is the first product that reduces serious RSV disease in high-risk children," said David A. Kessler, M.D., Commissioner of Food and Drugs. "In particular, during the flu season, repeated doses of the drug will benefit a significant number of prematurely born children in their first year of life, as well as children with chronic lung diseases up to age two."
In the United States, more than 90,000 children are hospitalized and 4,500 die each year from the disease.
RespiGam is made from plasma taken from large numbers of normal, healthy individuals and contains a high concentration of protective antibodies against RSV. These antibodies do not prevent RSV infections but help protect children against the most serious consequences of RSV.
RSVIGIV is given intravenously in five monthly doses, with the first dose given in November before the start of the RSV season. RSV outbreaks occur in the U.S. during the late fall, winter and early spring.
Data supporting the licensing of RespiGam was obtained in several clinical trials including a pivotal trial known as the PREVENT trial. This randomized, placebo-controlled double-blind study included 510 patients with BPD less than two years old or children under six months old with a history of premature birth (less than 35 weeks gestation).
RespiGam reduced the number of hospitalizations by 41 percent and time in the hospital by 53 percent in the PREVENT trial. In addition, children required fewer days of supplemental oxygen during their hospital stays.
On Dec. 15, 1995, FDA's Blood Products Advisory Committee reviewed the licensing application for RespiGam and recommended that the agency approve the product for marketing.
As with any human immune globulin product, rare allergic reactions to RSVIGIV are possible. In addition, infants with pulmonary disease may retain fluids and a small percentage of infants in the trials needed new or extra diuretics after receiving RSVIGIV.
Because the product is made from human plasma, a small risk exists for the transmission of blood-borne viruses. However, the risk is low because plasma donors are screened carefully and the product is treated with a solvent-detergent viral inactivation procedure which inactivates most significant blood-borne viruses, including the one that causes AIDS.