An experimental drug for Alzheimer’s disease, known as aducanumab, received widely-critical remarks by FDA panelists as to its efficiency in treating the disease.
The experimental treatment is theorized to clear clumps of the protein beta-amyloid from the brain, thus diminishing symptoms of cognitive decline.
Previous articles on this experimental drug, released in peer-reviewed journals, have advocated its purported results in its ability to combat the neurodegenerative disease. However, for some FDA panelists reviewing the drug’s purported efficiency, the evidence is just not strong enough for approval.
“Much of panel’s commentary was a rejection of the FDA’s viewpoint. Earlier in the day, the FDA’s chief staff reviewer gave a glowing review of the drug, calling study data submitted by Biogen “exceptionally persuasive,” “strongly positive” and “robust,” a news release of the FDA trial reads.
“But an FDA statistician noted flaws and inconsistencies in the results and potential safety issues. The drugmakers halted two studies of their drug last year after disappointing results,” the news release also states.
“But several months later the companies reversed course, announcing that a new analysis showed the drug was effective at a higher dose and that the FDA advised that it might warrant approval.”
The decision by FDA panelists arose at a time where over five million adults in the U.S. have been diagnosed with Alzheimer’s, in which an effective treatment for the condition is of urgency.
“If the drug is approved, the American Academy of Neurology urged the FDA to not make it a broad authorization, which could expose many patients to a medicine that might harm rather than help, and could overwhelm the health care system,” the news release concluded.