June 4, 1997 WASHINGTON, DC -- A new drug to prevent a form of pneumonia that kills 4,500 infants a year in the United States shows promise after preliminary clinical testing at Georgetown University Medical Center and nine other centers in the U.S.
The new drug, called MEDI-493, has undergone a double-blind, placebo controlled, dose escalation, multi-center, phase I/II trial evaluating important safety and pharmacological properties for treatment of respiratory syncytial virus in infants. MedImmune Inc. of Gaithersburg, MD, which supported this trial, has the exclusive worldwide marketing and manufacturing rights for MEDI-493. Respiratory syncytial virus (RSV) afflicts the underdeveloped lungs of premature infants, and is responsible for the hospitalization of 90,000 infants each year in the United States alone. The cost of treating a high-risk infant for RSV can be over $70,000.
Currently, a drug called RespiGam™ (Respiratory Syncytial Virus Immune Globulin Intravenous (Human)) is given to high-risk infants to prevent hospitalization due to RSV infection. At risk infants receive RespiGam™ once a month in a lengthy two to four hour infusion. RespiGam ™ is marketed in the U.S. by MedImmune in partnership with American Home Products Corporation.
MEDI-493 can be given more rapidly by infusion or by intra-muscular injection. If successful in phase III clinical trials, MEDI-493 has the potential to enhance patient care, reduce costs associated with drug administration and improve convenience for parents, physicians and nurses.
Dr. K.N. Siva Subramanian, the principal investigator in this study, presented the findings last month at the Pediatric Societies' Annual Meeting in Washington, DC.
# # # Commercialization of MEDI-493 will require prior approval from regulatory authorities, including the Food and Drug Administration in the United States. There can be no assurances that such approvals will be obtained.
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