Monday, December 18, 1995
By Steve Usdin
ROCKVILLE, Md. - Persistence paid off for another biotech product on Friday when the FDA's Blood Products Advisory Committee panel voted 8-3 to recommend approval of MedImmune Inc.'s RespiGam for respiratory syncytial virus in children.
The panel recommended approval of Respiratory Syncytial Virus Immune Globulin Intravenous (Human) "for prevention of serious lower respiratory tract infection caused by RSV in children < 24 months of age with bronchopulmonary dysplasia or a history of prematurity ( £35 weeks gestation)."
Committee members and FDA officials said the approval of RSV-IGIV was greatly facilitated by MEDI's commitment to conduct Phase IV trials to elucidate efficacy in sub-groups, especially very low weight infants and those who are under 6 months old.
MEDI shares gained $2.25 to close at $18.50 on Friday.
Specialty immune globulins are antibody products purified from human plasma and enriched in their content of antibodies against specific pathogens.