מטה ה-FDA במרילנד, ארה"ב
FDA headquarters in the United States
Photo: Reuters
Aducanumab, sold under the brand name Aduhelm

Israel becomes 1st country outside U.S. to use controversial Alzheimer's drug

Aducanumab — which aims to delay brain damage caused by the disease — was approved for use by the FDA last June, but rejected by EU regulators, citing concerns regarding treatment's safety and efficacy

i24NEWS |
Published: 01.11.22, 12:36
A controversial drug used to treat Alzheimer's disease was given to a patient in Israel on Monday, marking the first time the drug was used outside of the United States.
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  • Aducanumab, which is supposed to significantly slow down the progression of the disease, was approved by the Food and Drug Administration (FDA) in June 2021 in an unusually contentious debate and vote.
    2 צפייה בגלריה
    Aducanumab, sold under the brand name Aduhelm
    Aducanumab, sold under the brand name Aduhelm
    Aducanumab, sold under the brand name Aduhelm
    (Photo: AP)
    Dr. Tamara Shiner, a neurologist of the Cognitive Neurology Unit at the Tel Aviv Sourasky Medical Center in central Israel, said the “huge amount of controversy even through the approval by the FDA.”
    “Aducanumab reduces the amount of a certain protein involved in Alzheimer's. It’s one of the proteins involved in the disease, but not the only one,” Dr. Shiner added.
    “One of the questions is if this protein is essential to the disease. Then, if it's been cleared or reduced, does that stop the progression adequately.”
    It is the first new treatment for the neurocognitive disease since 2003. However, the global medical community has not reached a consensus.
    2 צפייה בגלריה
    מטה ה-FDA במרילנד, ארה"ב
    מטה ה-FDA במרילנד, ארה"ב
    FDA headquarters in Silver Spring, Maryland
    (Photo: Reuters)
    The European Medicines Agency rejected the drug’s approval, an independent U.S. advisory panel urged the FDA to renounce its approval, and top scientists continue to question the safety of human administration and whether the drug really works at all.
    “With Alzheimer’s disease, there are basically no drugs that slow its progression,” Dr. Shiner said.
    “There really isn't anything else that’s shown up until now to slow the pathological progression. As controversial as it may be, we still believe it's a lot better than anything we’ve had so far.”
    Shiner noted that the medical community is hoping that Aducanumab will become a “gateway drug” to many more medicines that can combat the disease’s progression.
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