Federal advisers on Friday voted to recommend that the Food and Drug Administration not approve what could be the first Alzheimer’s disease drug to hit the market since 2003.
If green-lit by the FDA, aducanumab would be the first-ever drug marketed to slow progression of the brain-wasting disease, according to developer Biogen. But the agency’s Peripheral and Central Nervous System Drugs Advisory Committee was unconvinced of the drug’s efficacy, voting 8 to 1 against recommending approval, with two more members undecided, reported MarketWatch.
Aducanumab has been shown to remove beta amyloid — a hallmark of Alzheimer’s — from the brain. But the drug has had a spotty clinical trial record, with studies halted in 2019. Biogen eventually applied for approval in July after an analysis showed that adults treated with higher doses during early-stage disease had slower decline in a number of key measures. These included cognition, memory, language, and activities of daily living performance.
The FDA is not bound to follow the committee’s vote and is due to make its decision by March 7, 2021.
Meanwhile, there has been contention among researchers about whether the drug should be approved. Some have gone on the record to question the current evidence and encourage more clinical trials. Others believe that the data — and the desperate clinical need — support approval of the drug, but recommend phase 4 studies to provide ongoing surveillance during a commercial rollout.