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More research questioning aducanumab
Posted: Tuesday, July 6, 2021 12:19 PM
Joined: 2/26/2016
Posts: 273

A new study gives evidence that amyloid plaques is not the driving factor in Alzheimers disease, but it is rather a consequence of the disease. It shows evidence that Alzheimers may develope as a result of the decline in amyloid-beta peptides. Therefore removing amyloid plaques, which the newly approved aducanumab effectively does, is not going to slow down Alzheimers. According to the study, an effective treatment would lie in normalizing the levels of amyloid-beta peptides.

Lane Simonian
Posted: Thursday, July 8, 2021 10:45 AM
Joined: 12/12/2011
Posts: 5130

The FDA is finally coming to its senses, either due to interanl or external pressures:

Aduhelm, also known as aducanumab, was studied in patients with early disease who tested positive for a component of amyloid brain plaques, but the FDA approval last month did not restrict its use to a specific group of patients.

Treatment with the drug should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, according to the updated product information on the drug.

The updated label, which was approved by the FDA after the company submitted it, also said there was no safety or effectiveness data on initiating treatment at earlier or later stages of the disease.