Aducanumab aims to remove sticky deposits of a protein called amyloid beta from the brains of patients in earlier stages of Alzheimer's in order to stave off its ravages.
"This is good news for patients with Alzheimer's disease. We've not had a disease modifying therapy approved ever," said Dr. Ronald Petersen, an Alzheimer's disease expert at the Mayo Clinic. However, he cautioned,"This is not a cure. It's hoped that this will slow the progression of the disease.
The FDA said Biogen will need to conduct a post-approval trial to verify Aduhelm's clinical benefit."If the drug does not work as intended, we can take steps to remove it from the market," it said. Aducanumab was studied in patients with early disease who test positive for a component of amyloid brain plaques. Some trial patients experienced potentially dangerous brain swelling.
Biogen and partner Eisai Co had scrapped development of the drug in March 2019, then reversed course in October, saying a more detailed data analysis showed some patients with very early forms of the disease benefited from taking higher doses over an extended period of time.
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