The FDA has approved a controversial new drug for the treatment of Alzheimer's disease, ignoring the recommendation by its own advisory panel to reject it.
In November, the Peripheral and Central Nervous System Drugs Advisory Committee voted 8 to 1 against approving the drug because, based on clinical trial results, evidence of efficacy was not strong enough. Two other members said they were uncertain on the issue of efficacy.
"Currently available therapies only treat symptoms of the disease; this treatment option is the first therapy to target and affect the underlying disease process of Alzheimer's," she added.The road to approval has been extremely rocky for aducanumab, an anti-amyloid-beta human monoclonal antibody, previously known as BIIB037.
BREAKING: US drug regulator grants historic approval to first Alzheimer’s drug designed to slow cognitive decline. A huge moment in the battle against dementia, but a controversial move as late stage trials of aducanumab were initially deemed a failure.However, 1 year later, a majority of the members of the FDA's advisory panel were against the drug's approval.
"The Alzheimer's Association urgently supports FDA approval of the treatment based on clinical trial results that showed a 22% reduction in cognitive and function decline — something that could make a meaningful difference" for patients, it said.
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