Alzheimer’s drug, FDA approved a new one

January 13, 2023 Helal Medical

The U.S. Food and Drug Administration on Friday approved a second Alzheimer’s drug, lecanemab, despite reports of rare brain bleeds linked to use of the drug in some patients.

Abou Alzheimer

Alzheimer’s disease is a serious health condition that causes health, psychological and social problems not only for the patient, but also for those around him/her. Therefore, we are all very eager for the emergence of a cure for Alzheimer’s. Most people know Alzheimer’s disease, or at least have heard about it. Perhaps you have a relative who suffers from it, or you learned about the disease through a movie.

The patient gradually loses his memory (dementia), cognition functions and his ability to perceive and judge what is going on around him, so his behavior becomes unacceptable and embarrassing to his relatives, and he eventually reaches madness.

Memory and language loss, impaired judgment, and other cognitive changes caused by Alzheimer’s disease make it difficult to treat other health conditions such as diabetes or high blood pressure, as the patient would not cooperate with others.

About Alzheimer’s drug, lecanemab

Alzheimer’s drug, lecanemab, is a monoclonal antibody. It is not a cure but works by binding to amyloid beta, a breakthrough for Alzheimer’s disease. In late November 2022, results from a Phase 3 clinical trial, published in The New England Journal of Medicine, showed that lecanemab “reduced markers of amyloid in early Alzheimer’s disease and resulted in moderately less decline on cognition function than placebo at 18 months but was associated with some adverse events.” It offers relief for people in the early stages of Alzheimer’s disease.

How Alzheimer’s drug, lecanemab, works?

Alzheimer’s drug, lecanemab is an antibody that sticks to amyloid-beta clumps that are found in the brains of people with Alzheimer’s disease. The drug signals the immune system to attack those clumps and clear them out. Therefore, it gives relief of symptoms and delays the decline in cognition function.

Why did the FDA approve lecanemab?

It is the second drug to be approved by FDA. The first one is Biogen’s drug aducanumab that was approved by the FDA in June 2021. Despite reports of rare brain bleeds linked to use of the drug in some patients., the FDA said it has many benefits, as well, see next paragraph.

Dr. Billy Dunn, director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said in an agency news release: “Alzheimer’s disease immeasurably incapacitates the lives of those who suffer from it and has devastating effects on their loved ones”. “This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer’s, instead of only treating the symptoms of the disease.”

Lecanemab, Alzheimer’s drug made by:

Lecanemab, made by Eisai and marketed by Biogen as Leqembi, will be only the second Alzheimer’s drug to receive the FDA’s blessing in the past 18 months. It generated controversy in the medical field over its lack of effectiveness, brain bleeding side effect and high price.

Aducanumab or Lecanemab?

Experts said it is somewhat different with Aducanumab: Dr. Sarah Kremen, leader of the Alzheimer’s Disease Clinical Trials Program at Cedars-Sinai in Los Angeles, said: “Unlike Aduhelm, which had an incomplete data set and where clinical trial data failed to demonstrate a definitive slowing in cognitive decline, lecanemab showed statistically significant slowing in cognitive and functional decline, as well as reduction of brain amyloid levels, and downstream beneficial effects on other markers of neurodegeneration”.

Also, Dr. Howard Fillit, co-founder and chief science officer of the Alzheimer’s Drug Discovery Foundation, said: “We need — and are on the way to having — multiple drugs we can combine to personalize treatments to match each patient’s Alzheimer’s pathology, which will have a much greater impact on slowing the disease.”

Still, Leqembi has been linked to two deaths from brain bleeds among people who used it in trials. And not every patient would stand to benefit from Leqembi, stressed the Cleveland Clinic’s Dr. Babak Tousi. He led the portion of the clinical trial that was conducted at the Cleveland Clinic, in Ohio.

“The trial was designed for patients in the earlier stage of Alzheimer’s disease, people with mild cognitive impairment or early stage of dementia,” Tousi noted. “It will probably be for people who have early stage of disease, with no to minimal assistance needed for activities of daily living.”

The results of the 18-month trial, which involved about 1,800 patients, gained wide attention when they were published Dec. 1 in the New England Journal of Medicine, Tousi noted.

In the trial, early-stage Alzheimer’s patients who took Leqembi showed a 27% reduction in their mental decline compared to patients in the placebo arm of the trial. The drug’s users also showed less evidence of amyloid protein plaques in their brain compared to non-users.

“Lecanemab clearly did what it was designed to do — it removed amyloid plaque,” said Tousi, who heads the Clinical Trials Program at the Cleveland Clinic Center for Brain Health. “The results demonstrated all the downstream effects we hoped would happen in terms of reduction of biomarkers and less clinical decline on several functional and cognitive measures. So, this difference will likely translate to a longer period of independent living for patients.”

SUMMARY

A new Alzheimer’s drug, lecanemab, has received accelerated approval from DFA. The approval comes after the medication showed promise in slowing disease progress in a phase 3 clinical trial. But there are some reports about few deaths, (3 persons), while taking the drug during the trial. Lecanemab is not a cure as per some experts, but it can reduce symptoms. Other officials at numerous Alzheimer’s organizations hailed the approval as an important milestone.