A month after the controversial approval of the first drug to deal with Alzheimer's disease, the Food and Drug Administration (FDA) rectified its initial decision and approved new prescription guidelines that will most likely limit its use.
The federal regulator explained in a statement Thursday that
the objective of the new guideline is to provide greater clarity
on what type of patients can use the drug, after the intense reaction against its initial approval by much of the medical community.
The new label of the drug Adulhelm will specify that its use is only appropriate for patients with early stage Alzheimer's.
The original instructions included all Alzheimer's patients, regardless of how advanced their case was.
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The pharmacist that makes the drug, Biogen, explained Thursday that the label now reflects the results of laboratory tests, which indicate that the treatment is safe and effective for people with early Alzheimer's,
the population group that participated in the study.
.
"Upon learning of these concerns, the FDA determined that the prescription information for the drug could be clarified," he told The Associated Press news agency in an emailed statement.
Photo distributed by the pharmaceutical laboratory Biogen on June 7, 2021, showing a bottle and container of the drug Aduhelm.
AP
However, the FDA added that
"some patients may benefit from treatment"
even when their disease is in a more advanced stage.
Federal authorities initially claimed that the drug was "appropriate for all stages of Alzheimer's," but its approval sparked controversy due to the lack of hard evidence and the high price ($ 56,000 for a year of treatment).
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Three independent FDA experts resigned after last month's ruling, which was made against the recommendation of the federal administration's advisory council, and a well-known Harvard University expert called it "the worst drug decision in recent history. of the United States ".
Aduhelm has not been shown to significantly reverse or slow the disease
.
But the FDA said its ability to reduce plaque buildup in the brain is likely to curb dementia.
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Biogen will need to complete a new study to definitively determine whether the drug slows mental decline.
Other Alzheimer's medications only temporarily relieve symptoms.
Some analysts have drawn attention to the possibility that the high price of the drug and the wide range of patients who are candidates for it in the United States
could cost the federal government billions of dollars
.
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Some six million Americans have Alzheimer's, and most of them qualify for public Medicare insurance.
"It is a responsible decision by both the FDA and Biogen that maximizes safety while giving the drug the best chance to work," Dr. Ronald Petersen of the Mayo Clinic, who has been an advisor to Biogen, told The Associated Press. .
With information from The Associated Press and The Washington Post.