New Aduhelm label disregards Biogen’s call for diagnostic  

The revised Aduhelm label released Thursday calls for initiating therapy in early stage Alzheimer’s patients, which is consistent with clinical trial data and is in accord with statements from Biogen and Eisai. Unlike the clinical trials, and in contrast to recommendations from the drug’s manufacturers, the new label does not mandate or recommend diagnostic tests to confirm the presence of β-amyloid.

The addition of an imaging requirement would not satisfy critics who contend that FDA’s confidence in the amyloid hypothesis is misplaced, but it could address concerns that misdiagnosed patients will be exposed to risks of serious adverse events, and incur substantial costs, with no potential for benefit. ...