On Monday 07th June 2021, the Food and Drug Administration (FDA) have given approval for a hopefully ground-breaking drug to fight the Alzheimer’s Disease. This is an historical move with much controversy from the scientific community.
Adulhelm will not reverse the disease’s progression and is not a cure, but the new drug is designed to slow down the cognitive decline in the Alzheimer’s Disease. Although this is a marginal decline, it opens new pathways for research.
The difference from preceding drugs, is that those drugs treat the symptoms while Adulhelm is the first to attack the underlying cause of the disease.
Toxic protein is believed to destroy neurons which in turn causes dementia. Adulhelm is said to destroy clumps of this toxic protein.
“This historic moment is the culmination of more than a decade of ground-breaking research in the complex field of Alzheimer’s disease. We believe this first-in-class medicine will transform the treatment of people living with Alzheimer’s disease and spark continuous innovation in the years to come”, Biogen CEO Michel Vounatsos said in a statement.
The controversy behind the FDA’s decision is that it was approved based solely on its ability to clear the toxic proteins, with independent experts finding there is not enough evidence that the treatment has significant benefits to the patients.
Biogen, the creator of the drug, will need to complete a large clinical trial to confirm the benefits, which would be that Adulhelm will remove the plaque for cognitive benefits. Should the study fail, the FDA has the authority to retract its approval.
Caleb Alexander, a Johns Hopkins Epidemiologist who served on the FDA’s advisory panel and voted against the approval of Adulhelm said: “I’m quite surprised. The most compelling argument for approval was the unmet need but that cannot, or should not, trump regulatory standards. It’s hard to find any scientist who thinks the data is persuasive. Unmet need is an important contextual factor but it’s not an evidentiary threshold.”
Sources:
STAT News
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