NEWS

01/19/1996



<TITLE> FDA LICENSES FIRST PRODUCT TO PREVENT SERIOUS RSV DISEASE

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P96-1                                Lenore Gelb

FOR IMMEDIATE RELEASE                (301)  443-3285

January 19, 1996                                    



    FDA LICENSES FIRST PRODUCT TO PREVENT SERIOUS RSV DISEASE



     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  

                             -more-

                                Page 2, P96-1, RSV Disease

significant number of prematurely born children in their first

year of life, and 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 is designed to contain 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.  

                               -more-                                    Page 3, P96-1, RSV Disease

     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.

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