Nashville-Davidson, Tennessee 2021-06-07 11:23:34 –
(Reuters)-US regulators approved Biogen’s aducanumab as the first treatment to address the root cause of Alzheimer’s disease on Monday.
Aducanumab aims to remove sticky deposits of a protein called amyloid beta from the brains of patients in the early stages of Alzheimer’s disease to stop damage such as memory loss and the ability to care for themselves.
The Food and Drug Administration (FDA) said clinical trials of this treatment, marketed under the Aduhelm brand, showed a reduction in plaque that was expected to lead to a reduction in the clinical decline of patients.
“Although Aduhelm data are complex in terms of their clinical benefits, the FDA has substantial evidence that Aduhelm reduces amyloid beta plaques in the brain, and the reduction of these plaques predicts significant benefits for patients. We have determined that there is a reasonable possibility, “the agency said in a statement.
Biogen drugs have been welcomed by patient advocates and some neurologists who aspire to have effective options for patients with fatal illnesses. Other doctors said the results of clinical trials were inconsistent and needed more evidence.
The FDA said Biogen needs to conduct post-approval clinical trials to verify the clinical efficacy of the drug.
“If the drug doesn’t work as intended, we can take steps to remove it from the market,” the company said.
Aducanumab was studied in patients with early-stage disease who are positive for amyloid brain plaque components. Some study patients experienced potentially dangerous swelling of the brain.
Biogen estimates that approximately 1.5 million Americans are eligible for treatment with aducanumab, and aducanumab is given as a monthly infusion, raising concerns about the cost of the healthcare system.
Stocks were suspended until the news came out.
FDA approves controversial Biogen Alzheimer’s drug Source link FDA approves controversial Biogen Alzheimer’s drug