Companies already knew beforehand that Alzheimer drugs are a multi-billion dollar market.
But they didn’t know how willing the FDA was to approve placebo-like drugs.
Cassava Sciences, whose Alzheimer drug candidate doesn’t target beta amyloid, rose in response to that approval. I doubt that many people will be satisfied enough with this drug to deter signups for new trials.
I don’t know what the net effect will be on the development of good drugs, and I doubt that anyone else does either.
The drug isn’t just an inert sugar pill. Placebo’s don’t cause bleeding in more then 10% of the patients. Additionally it does change a metric in the right direction. It’s just not a metric that’s clinically beneficial.
That suggests that other drugs that also target metrics that aren’t clinically benefitial might get approved.
I doubt that many people will be satisfied enough with this drug to deter signups for new trials.
It results in trials being more work because they now have to make an argument about how their treatment relates to the “state of the art”. That might mean having a control group that takes expensive aducanumab.
But they didn’t know how willing the FDA was to approve placebo-like drugs.
Cassava Sciences, whose Alzheimer drug candidate doesn’t target beta amyloid, rose in response to that approval. I doubt that many people will be satisfied enough with this drug to deter signups for new trials.
I don’t know what the net effect will be on the development of good drugs, and I doubt that anyone else does either.
The drug isn’t just an inert sugar pill. Placebo’s don’t cause bleeding in more then 10% of the patients. Additionally it does change a metric in the right direction. It’s just not a metric that’s clinically beneficial.
That suggests that other drugs that also target metrics that aren’t clinically benefitial might get approved.
It results in trials being more work because they now have to make an argument about how their treatment relates to the “state of the art”. That might mean having a control group that takes expensive aducanumab.
Crappy drugs that only slow the decline a bit might need an aducanumab comparison, but why would a drug that reverses the decline need that?
See Cassava’s trial results.
See also this clinical trial of Bredesen’s approach (press release here).