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Despite questions surrounding its efficacy, the Food and Drug Administration on Monday approved a groundbreaking new medication that attacks the underlying Alzheimer’s disease process rather than treating just its symptoms, writes The New York Times. It is the first drug of its kind, and the first new Alzheimer’s treatment in 18 years.
Aducanumab, the drug developed by biotech company Biogen and Japanese pharmaceutical company Eisai, reduces levels of amyloid, an Alzheimer’s biomarker and protein that “clumps into plaques” in a patient’s brain, the Times writes. However, experts and doctors remain divided over whether this will have a substantial-enough effect to warrant approval, particularly as amyloid protein reduction may help only patients early in their disease progression, Time reports. On top of that concern, clinical trials also saw instances of brain swelling or bleeding, leading others to wonder if the risks outweigh the benefits, writes the Times.
Critics cite two conflicting aducanumab clinical trials in explaining their hesitation — one study showed positive cognitive effects, and the other reportedly showed none at all. Biogen later claimed its “initial read of the data was incomplete,” Time writes, and the FDA will now require the manufacturer to conduct another, post-approval trial to verify its claims. The infusion-based treatment will still be available to patients in the meantime, per the Times.
Even with outstanding questions about aducanumab’s “modest” clinical effect, supporters view the drug’s approval as a win in the fight against an incredibly debilitating disease, says Time. “What we are trying to do is to delay the disabling phases of the disease and preserve quality of life,” said Dr. Stephen Salloway, one of the principal investigators for the aducanumab trials, “Although the data has issues, this drug offers some chance of doing that.”