MedImmune not compelled to add RespiGam trials

MedImmune Inc. (MEDI) has decided not to run any new trials of RespiGam, its polyclonal antibody to treat respiratory syncytial virus, despite the unanimous decision by the FDA Blood Products Advisory Committee last December to recommend against approval of the drug. "We saw no reason to do anything else," David Mott, vice president for business development and planning, told BioCentury.

The panel had criticized a completed trial of the product in 249 infants at risk for RSV for possible enrollment bias, and for six deaths in the treatment arm, among other concerns. At the time, the company noted that the trial had not been under its control at inception, but had been designed by the Massachusetts Health Research Institute and others. MEDI licensed the product from MHRI as the trial was proceeding. ...