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T98-35                        Print Media:        301-827-6242
June 19, 1998                 
                              Consumer Inquires:  800-532-4440

FDA LICENSES BIOTECH PRODUCT TO PREVENT SERIOUS RSV DISEASE

FDA today approved a monoclonal antibody 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.

The product, palivizumab, is a genetically engineered antibody against the RSV virus. This antibody is manufactured using human and mouse antibody genes and can be produced consistently on a large scale.

Palivizumab is the second product licensed for RSV disease. The first one, RSV Immune Globulin Intravenous (Human) (RSVIGIV) is made from human plasma and is marketed as RespiGam by MedImmune Inc, Gaithersburg, Md, the same company marketing palivizumab.

Both palivizumab and RSVIGIV are approved for use in high risk infants under two years old with lung problems related to chronic bronchopulmonary dysplasia (BPD) or prematurity. Both products were found effective in reducing the number of hospitalizations due to RSV.

Although both products must be given in five monthly doses, the new product, palivizumab, is given intramuscularly, rather than by intravenous infusion over a period of hours. In addition, palivizumab is more concentrated than RSVIGIV, an advantage since infants with certain pulmonary diseases may retain excess fluids.

In the United States, estimates are that more than 90,000 children are hospitalized and 4,500 die each year from RSV disease. The RSV outbreaks occur in the U.S. during the late fall, winter and early spring. The first dose of either product is given in November before the start of the RSV season.

Medimmune Inc., the manufacturer of palivizumab, has formed a marketing alliance with the Ross Products Division of Abbott Laboratories to sell the new market under the brand-name Synagis.

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