Doctors Frustrated By Lack Of Guidance On Who Should Get Aduhelm

Broad Label Has No Requirement To Test For Amyloid

Biogen has warned that uptake for its newly approved Alzheimer’s therapy will be slow in the beginning and doctors confirm it will take time to figure which patients can and should be treated.

Woman of the nursing service consoles sad senior citizen in the nursing home
Pivotal trials tested Aduhelm in patients with early Alzheimer's disease and mild cognitive impairment • Source: Alamy

Doctors who treat patients with Alzheimer’s disease – even neurologists involved in clinical trials for Biogen, Inc./Eisai Co., Ltd.’s Aduhelm (aducanumab) – are unsure who actually should be treated with the drug and who will pay for it based on the broad label approved by the US Food and Drug Administration.

Scrip spoke with physicians who expressed frustration with the FDA’s 7 June decision to grant accelerated approval based on Aduhelm’s...

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