Though Pfizer performed a radiographic analysis in one tofacitinib study, the agency perspective on these data was less than sanguine however. On pages 14-18 of the FDA briefing document on the Pfizer data, there were 5 concerns raised regarding these data (see document text). Thus the agency concluded that "it is not possible to make definitive conclusions about the treatment effect of tofacitinib on structural damage progression. This is particularly important in determining the overall benefit-risk profile of tofacitinib, which is associated with serious safety concerns..."
Is it safe to assume that AZN/RIGL incorporated a radiographic study into the ongoing pivotal fostamatinib trials?
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