The United States (US) Food and Drug Administration (FDA) has approved the medication, Aducanumab, as the first novel therapy for Alzheimer’s disease since 2003.
The drug is marketed as Aduhelm. In a statement, the FDA says the drug is the first treatment directed at the underlying pathophysiology of Alzheimer’s – a reference to the amyloid beta plaques in the brain.
Aduhelm is administered as a monthly intravenous infusion intended to slow cognitive decline in people suffering the early stages of Alzheimer’s disease. It is the first approved drug to slow the disease process rather than managing just the symptoms associated with it.
The FDA says clinical trials were the first to show a reduction in the brain plaques, which is a hallmark finding in the brain of patients with Alzheimer’s disease and could therefore lead to a reduction in the clinical decline of this devastating form of dementia.
The FDA decision goes against an independent advisory panel that issued a recommendation late last year not to approve the drug. The FDA’s subsequent approval indicated that it considered the concerns and decided the benefits outweighed the risks of the therapy.
It also wants the drug manufacturer Biogen to conduct post-approval studies to verify the anticipated clinical benefit – a process that could lead to removing the medication from the market if those trials don’t affirm the drug’s anticipated benefit.
FDA’s Decision to Approve New Treatment for Alzheimer’s Disease https://t.co/TnsSMUN1pj
— Sherwin Bryce-Pease (@sherwiebp) June 7, 2021