FDA Reverses Broad Approval For Controversial Alzheimer’s Drug

Topline

The FDA has greatly limited who it says should be given the Alzheimer’s drug Aduhelm, which it approved last month for all patients despite the drug being designed for those dealing with mild symptoms.

Key Facts

A new label on the drug’s packaging now recommends it only be given to early stage Alzheimer’s patients.

On June 7, the FDA approved the drug for all patients, despite concerns over its effectiveness and cost.

The drug comes with a price tag of $56,000 a year, which does not include costs for additional testing and scans patients would need.

The expensive cost of Aduhelm combined with the fact around 6 million Americans suffering from Alzheimer’s disease would have been eligible—and unlikely to benefit from the drug—sparked concerns it would have caused an undue financial burden for Medicare.

Around 2 million Americans will still be eligible will be eligible under the revised drug labeling, according to The New York Times.

Surprising Fact

An independent FDA advisory panel told the agency it should not approve the drug, but the FDA did so anyway. Three members of the panel resigned following the decision.

Key Background

Biogen—the drug’s manufacturer—conudcted two clinical trials of Aduhelm, with limited success. The first trial showed a promising 22% reduction in cognitive decline, but the second trial yielded no positive results at all. A third trial is being required as part of the FDA approval, but that process will likely takes years. The approval process also came with concerns that heavy lobbying from Biogen and groups like the Alzheimer’s Association influenced the FDA’s decision-making.

This is a developing story. Check back for updates.

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