A new analysis finds that the clinical trials conducted by Biogen (BIIB) for its controversial Alzheimer’s treatment would have excluded as many as 92% of Medicare beneficiaries — a key portion of the targeted patient population — based on their age or existing medical conditions.
Breaking it down, a total of 92% of patients with Alzheimer’s and related disorders, 91% with Alzheimer’s specifically, and 85.5% with mild cognitive impairment met at least one of the criteria for exclusion from the studies, according to the analysis published in JAMA. The most common criteria were heart disease, conditions associated with blood clots, chronic kidney disease, and an age of 85 years or older. Most people actually met more than two of the criteria used for excluding participants.
“These findings are concerning given the broad labeling” that the Food and Drug Administration approved for the drug, which is called Aduhelm, the researchers wrote. “Though labeling has recently been narrowed to focus on patients with mild cognitive impairment or mild-stage dementia, no contraindications (or precautions for using the medication) have been added.”
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