Biotech Values

[biomaven0]

Why wouldn't AZN run a head-to-head study to try to differentiate FosD from patients who have yet to try anti-TNF therapy? Is AZN afraid of a poor outcome on this front?

Here's my best guess:

The population AZN is studying is a tougher one than the broader RA population, and so proving efficacy against a placebo will actually be harder than it would be in the general RA population. But these days the FDA is all about risk vs benefit, and so the safety bar is implicitly lower for patients with an unmet need. Their drug is not quite clean (the hypertension issue) and so they have elected to go for the tougher population with an unmet need.

Note that the anti-TNF biologics are not without their safety concerns too, but doctors are now used to them.

Peter