Alzheimer drug approved, page-6

https://endpts.com/fda-oks-aducanumab-for-alzheimers-turning-controversial-biogen-drug-into-a-megablockbuster/

The approval, however, will do little to quell criticisms from the swath of Alzheimer’s researchers, biostatisticians, and clinicians who have argued that Biogen cherry-picked data and failed to show convincing evidence that the drug can slow patients’ cognitive decline. In green-lighting aducanumab, the FDA overruled the near-unanimous recommendation of its advisory committee, who excoriated both Biogen and the agency in a withering marathon session last fall.

“I almost fell out of my chair,” Caleb Alexander, an epidemiologist at Johns Hopkins and one of the members of that committee. “I think it’s possible but unlikely that there’s new data that hasn’t been shared, but barring that it’s simply hard to see. At best I can tell, the magnitude of unmet need has driven this product forward in spite of the paucity of persuasive evidence.”