Monday, December 6, 1993
By Karen Bernstein
MedImmune Inc. on Friday moved to distance itself from the conduct of the privotal trial of RespiGam, which was unanimously rejected last week by the FDA Blood Products Advisory Committee.
While expressing confidence in the safety and efficacy of the drug as a prophylactic in children at high risk of respiratory syncytial virus, company executives emphasized that the rejected study had been designed by Massachusetts Health Research Institute, The Children's Hospital in Denver and the National Institute of Allergy and Infectious Diseases. MEDI licensed the polyclonal antibody from MHRI.
A new trial, if conducted, would be under MEDI's control, according to both President and CEO Wayne Hockmeyer and David Mott, vice president of business development and planning.
Advisory panel members hammered on the trial's conduct, saying the data could not be trusted because of enrollment procedures at the Denver trial site, increased occurrences of RSV at Denver, the lack of statistically significant outcomes at the other individual trial sites, and lack of follow-up data on 17 patients who dropped out of the trial.