Biotech Values

[DewDiligence]

Do Raptiva PML cases change the FDA's mindset?

I would like to start a new thread: Raptiva and PML. Any opinions as to how these latest safety issues might effect future immunosuppressive drugs to come before the FDA, specifically FTY-720 and Cladribine?

It’s hard to imagine how the FDA could become any more cautious about new-drug approvals than it already is, so my initial assessment is that the Raptiva/PML development does not change the FDA’s approval threshold to a material degree.

This is not a new story. If you look at the FDA’s non-approval decisions during the past few years on such cases as Galvus, Bridion, and Sparlon, the pattern is pretty clear. From #msg-31148666:

“It looks like the FDA is in a bunker-down mode,
with Congress all over them. They're taking an
extraordinarily cautious approach.”
—Barbara Ryan, Deutsche Bank