Biotech Values

[biotech jim]

Although not required for earlier RA drugs, the agency now wants one radiographic study with a large treatment effect.

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..."

So based on this, do you feel that the agency will approve the drug? It sure seems that these Pfizer data may be (or remain) problematic. I did not see Pfizer alleviate any of the agency concerns in this regard. I do agree with the agency concerns here, and this was my basis in part that Pfizer would only obtain a plurality vote.

BJ