FDA to "revisit" intravenous immune globulin clinical trial design.
FDA's current trial design recommendations for primary immune deficiency is a 12-month, single-arm, open study of roughly 50 patients. The trial design assumes 80% power to detect the historical control of a 20% adverse event rate per IGIV infusion.
"In sharp contrast to what we are hearing today, we assumed [from] looking at all the trials that we could gather at that time that the adverse event rate for IGIV per infusion was 20%," Golding said.
"What we're hearing today is that it's less than 1%. So, this is one aspect of the trial design that we need to revisit and maybe change our actual numbers."
FDA developed its IGIV clinical trial recommendations in 1999 and 2000 to address product shortages and spur product development.
Three new IGIV products have been approved since FDA proposed the trial design: Bayer's Gamunex and Instituto Grifols' Flebogamma were approved in 2003, and Octapharma's Octagam was approved in 2004.
The agency is also considering development of an IGIV repository to monitor trends in antibody levels and assess emergence of potential protection against new pathogens. The repository would contain five random lots of product submitted by each IGIV manufacturer every year. Product would be coded and frozen. "Who can request these for testing? I think certainly FDA would be among those, CDC as well. But also outside investigators in industry might be interested," CBER Laboratory of Plasma Derivatives Branch Chief Dorothy Scott said.
The repository would also allow for a comparison between licensed and unlicensed products, she noted.
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|Title Annotation:||Regulatory Update|
|Date:||May 1, 2005|
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