FDA/Regulatory
GSK submits non-statistically significant NDA for Promacta
An FDA reviewer said that Promacta, an experimental platelet-boosting drug seeking an indication for acute treatment of chronic idiopathic thrombocytopenia purpura from GSK, did not help control bleeding any better than a placebo. The reviewer wrote:
“The data provided in this NDA (new drug application) do not demonstrate statistically significant, robust … treatment effect in decreasing bleeding events,”
The FDA is already being stingy about approving NDAs when they demonstrate statistically significant effects. I can’t imagine the advisory board, which meets Friday, is going to issue a positive opinion about recommending an acute therapy for a chronic disease state, especially with non-statistically significant results.
I’m not a regulatory guy, so anyone want to explain the GSK reasoning to me?
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