UPDATED: Biogen narrows its Aduhelm label after FDA left the floodgates open
While the FDA had controversially approved Biogen’s new Alzheimer’s drug Aduhelm with a wide label for anyone with the debilitating disease, Biogen announced Thursday morning that it’s narrowing the drug’s label as part of an attempt to calm at least some of its fiercest critics.
The unprecedented move means that the label now says that Aduhelm should be initiated in patients with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s dementia, which is reflective of the population in Biogen’s failed but resurrected clinical trials for the drug. The narrowed population may limit how much Medicare ends up spending on the drug, although if even a fraction of those with Alzheimer’s gain access to the drug, Biogen is likely to reap tens of billions of dollars per year from it.
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