Aducanumab, the controversial Alzheimer's drug that was approved in the US.

By: DW.

The US regulatory authority approved Biogen Inc.'s aducanumab on Monday (06/07/2021) as the first treatment to address an underlying cause of Alzheimer's disease, despite controversy over the mixed results of clinical trials for the drug.

Aducanumab aims to remove sticky deposits of a protein called beta amyloid from the brains of patients in the early stages of Alzheimer's – the sixth leading cause of death in the US – to prevent its ravages, including memory loss. and the ability to take care of oneself.

The Food and Drug Administration (FDA) said clinical trials of the treatment, which will be sold under the brand name Aduhelm, showed a reduction in plaques that is expected to lead to a reduction in the clinical deterioration of patients.

"Although the Aduhelm data are complicated regarding its clinical benefits, the FDA has determined that there is substantial evidence that Aduhelm reduces beta amyloid plaques in the brain and that reducing these plaques is reasonably likely to predict important benefits for patients. patients"the agency said in a statement.

Biogen's drug had been hailed by patient advocates and some neurologists eager for an effective option for patients with the deadly disease. Other doctors said that the results of clinical trials were inconsistent and that the evidence about its benefits is not enough.

The> Biogen must conduct a post-approval clinical trial to verify the clinical benefit of the drug: "If the drug does not work as intended, we can take steps to withdraw it from the market", He said.

The aducanumab studied in patients with early stage disease who tested positive for a component of brain plaques amyloid. However, some trial patients experienced potentially dangerous brain swelling.

Biogen has estimated that about 1.5 million Americans could be treated with aducanumab, which is administered through a monthly infusion, which raises costs for the health system.

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