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FDA Narrows Indication for Biogen’s Aduhelm in Alzheimer’s Disease

By July 19, 2021May 26th, 2022No Comments

FDA Narrows Indication for Biogen’s Aduhelm in Alzheimer’s Disease

News came last week that after the controversial early-June approval of Aduhelm, the first new treatment for Alzheimer’s disease in almost 20 years, the FDA (at manufacturer Biogen’s request) had narrowed its recommendation of who should receive it. The revised prescribing information now states that Aduhelm should be used in subset of patients with Alzheimer’s—those with mild dementia or mild cognitive impairment—rather than any patient with Alzheimer’s regardless of the level of severity. The clinical trials that led to its approval included only patients with mild disease and the confirmed presence of amyloid.

The FDA’s move to limit Aduhelm’s use to a specific type of patient underscores the importance of matching the right patient with the right treatment. And that means clinicians must have access to reliable tests to help them identify the patients most likely to benefit from a particular treatment. Individualized patient care depends on it.

CND Life Sciences

CND Life Sciences is the creator of the Syn-One Test™, the world’s first commercially available test to visualize abnormal, phosphorylated alpha-synuclein in cutaneous nerve fibers. The test is an objective, evidence-based diagnostic tool to aid in the diagnosis of Parkinson’s disease, dementia with Lewy bodies, multiple system atrophy, pure autonomic failure, or REM sleep behavior disorder.