A month after approving a controversial new Alzheimer’s drug, U.S. health regulators on Thursday signed off on new prescribing instructions that are likely to limit its use.
Such sweeping changes to drug labels are rare, particularly only a few weeks after approval.
Aduhelm hasn't been shown to reverse or significantly slow the disease. But the FDA said that its ability to reduce clumps of plaque in the brain is likely to slow dementia. Many experts say there is little evidence to support that claim. Because of its price and broad approval some analysts have worried that Aduhelm could add tens of billions in new expenses to the U.S. health care system, particularly the federal government's Medicare program. Alzheimer’s affects about 6 million Americans, the vast majority old enough to qualify for Medicare.
The narrower label may ease some of those concerns by shrinking the number of patients likely to get the drug, which requires monthly IVs. Many hospitals have already stated that they plan to limit the drug's use to patients with earlier stage disease. Doctors could still prescribe the drug for more advanced patients, though insurers might refuse to pay for it, citing the FDA label.
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