The Food and Drug Administration approved a new drug for Alzheimer’s disease Monday, purportedly giving doctors a new but much-debated method of directly addressing the Alzheimer’s disease process instead of merely treating the symptoms of it.
The drug, called aducanumab, was approved through the FDA’s accelerated approval program, which is reserved for drugs that “fill an unmet medical need based on a surrogate endpoint” but that do not definitively improve patient outcomes. As Stat News notes, this means that, while the drug has shown it can eliminate the toxic protein clumps experts believe contribute to dementia, the regulatory agency doesn’t know definitively if it actually helps improve cognition in the patients who receive it.
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