Alzheimer’s drug lecanemab granted full approval by FDA, Mayo Clinic expert weighs in

The Food and Drug Administration (FDA) granted conventional approval of a disease-modifying therapy that might doubtlessly give some sufferers with Alzheimer’s disease one thing they haven’t had earlier than: a drugs which will gradual the decline of reminiscence and pondering.

A monoclonal antibody, lecanemab, exhibits promise in eradicating amyloid plaques from the mind, based on phase 3 trial results. Amyloid plaques are one of many defining options of Alzheimer’s illness, based on Dr. Ronald Petersen, a neurologist and director of the Mayo Clinic Alzheimer’s Disease Research Center.

Watch: Dr. Petersen discusses FDA approval

Journalists: Broadcast-quality video is on the market in the downloads on the finish of the publish. Please courtesy: Mayo Clinic News Network. Name tremendous/CG: Ronald Petersen, M.D., Ph.D./Alzheimer’s Disease Research Center/Mayo Clinic.

“Amyloid is one of the key proteins involved in Alzheimer’s disease. It’s thought that by removing amyloid from the brain, you will slow down the rate of progression of the disease. Now, importantly, it doesn’t stop the disease. It doesn’t make people better, but it will slow down the rate at which the disease progresses so people remain functional for a longer period of time,” says Dr. Petersen.

Brain adjustments related to Alzheimer’s illness can result in rising hassle with:

  • Memory
  • Thinking and reasoning
  • Making judgments and choices
  • Planning and performing acquainted duties
  • Changes in character and conduct

As with any drug, Dr. Petersen says lecanemab has potential negative effects which might be severe. Who could be a superb candidate for this therapy?

“Lecanemab does, in fact, remove amyloid from the brain, but it may also remove amyloid from the blood vessels in the brain,” he explains. “This may render them leaky, such that people on this drug may develop some swelling in the brain and may develop some bleeding in the brain. This can be monitored by MRI, and usually the side effects have been mild and moderate.”

Dr. Petersen says the info from the lecanemab research have been an necessary step ahead in the struggle in opposition to a illness which robs sufferers of their most human qualities.

“It shows that we now may have the ability to actually modify the underlying disease process. Heretofore, we’ve had symptomatic drugs for Alzheimer’s disease, but they do not actually get at the underlying disease process. Drugs like lecanemab now actually alter the disease process itself and will slow down the rate of progression. That’s a major step forward,” says Dr. Petersen.

“This gives us an opportunity to perhaps add other drugs that may have additive mechanisms of action to actually slow down the disease process even more dramatically.”

Who could be a superb candidate for this therapy?

Dr. Petersen says it’s necessary to notice that this therapy isn’t meant for all dementia sufferers.

“It’s likely that lecanemab will be used for people who have the mildly symptomatic phases of Alzheimer’s disease. So clinically, we call that mild cognitive impairment or mild dementia due to Alzheimer’s disease. These were the people who are actually involved in the phase 3 clinical trial that demonstrated the effectiveness of the drug.”


Dr. Petersen has beforehand consulted with Biogen and Eisai, makers of lecanemab. He was not concerned in the design or execution of medical trials for lecanemab.

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