U.S. approval of a medication that removes a key marker for Alzheimer’s disease sharply divided clinicians and advocates over whether it has the ability to change the disease’s progress and how it will be used.
Biogen Inc.’s aducanumab was approved by the U.S. Food and Drug Administration Monday based on its ability to remove amyloid plaques in the brain, long seen as a surrogate for the mind-robbing disease that’s been diagnosed in about 5.7 million Americans. The accelerated approval requires added study of the drug and leaves open the chance it could be taken off the market if it fails to show true benefit.
The decision came despite opposition from the FDA’s independent advisory committee, and with the agency saying that evidence from clinical trials was incomplete on the drug’s effectiveness. Still, one thing is clear: Having the drug on the market will change Alzheimer’s care, at least for some patients, and the FDA’s green light might pave the way for future therapies.
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