4 ms·
unless its for Alzheimer's? [0] 'The FDA’s eventual decision to ignore the advice of its advisory committee and approve the drug, it says, was based on aducanu
by moh_maya 4y ago
unless its for Alzheimer's? [0]
'The FDA’s eventual decision to ignore the advice of its advisory committee and approve the drug, it says, was based on aducanumab’s ability to lower levels of amyloid plaques in the brain — protein clumps that some scientists think cause Alzheimer’s.'
...
With aducanumab, the agency has shown that it is willing to push the paradigm to a broader set of people. One reason that decision has attracted criticism is that decreased levels of amyloid plaques are an unvalidated and contentious marker of a drug’s activity.
In large trials of other Alzheimer’s drug candidates, amyloid lowering has not led to cognitive benefits, and this has made it a sticking point for researchers.' [0]
[0] https://www.nature.com/articles/d41586-021-01763-9 https://www.nature.com/articles/d41586-021-01763-9
- nick__m 4y agoI wonder if those amyloid lowering drugs could have a prophylactic effect while having no curative effects. I would love to see a trial in people at high risk of Alzheimer...
- refurb 4y agoThey are already doing those and they aren’t working out too well either.
- refurb 4y agoIndeed! The Alzheimer’s drug was an Accelerated Approval. Basically conditional, based on a “likelihood” that the biomarker is indicative of a benefit, but requiring further study to prove benefit.