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Alzheimer's drug lecanemab gets accelerated US approval amid safety concerns


The FDA granted accelerated approval Friday for the Alzheimer's disease drug lecanemab, one of the first experimental dementia drugs that appears to slow the progression of cognitive decline.

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(CNN) --

The US Food and Drug Administration (FDA) granted accelerated approval Friday for the Alzheimer's disease drug lecanemab, one of the first experimental dementia drugs that appears to slow progression. of cognitive decline.

"Alzheimer's disease immensely cripples the lives of those who suffer from it and has devastating effects on their loved ones," Dr. Billy Dunn, director of the Office of Neuroscience at the FDA's Center for Drug Evaluation and Research, said in a statement. .

"This treatment option is the latest therapy to target and affect the underlying Alzheimer's disease process, rather than just treating the symptoms of the disease."

Lecanemab will be marketed in the United States as Leqembi, according to the FDA statement.

It has shown "potential" as a treatment for Alzheimer's disease because it appears to slow progression, according to phase 3 trial results, but has raised safety concerns because of its association with certain serious adverse events, including swelling and brain bleeding.

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In July, the FDA accepted Eisai's biologic license application for lecanemab under the accelerated approval pathway and granted the drug priority review, according to the company.

The accelerated approval program allows earlier approval of drugs that treat serious conditions and "fill an unmet medical need" while the drugs continue to be studied in larger, longer trials.

If those trials confirm that the drug provides clinical benefit, the FDA could grant traditional approval.

But if the confirmatory trial shows no benefit, the FDA has regulatory procedures that could lead to removing the drug from the market.


What is known about lecanemab

Lecanemab, a monoclonal antibody, is not a cure but works by binding to beta amyloid, a hallmark of Alzheimer's disease.

In late November, results of an 18-month Phase 3 clinical trial published in The New England Journal of Medicine revealed that lecanemab "reduced amyloid markers in early Alzheimer's disease and resulted in a moderately smaller decrease in measures of cognition and function than placebo at 18 months, but was associated with adverse events.

Results also showed that about 6.9% of trial participants who received lecanemab, as an intravenous infusion, discontinued the trial due to adverse events, compared to 2.9% of those who received placebo.

Overall, serious adverse events occurred in 14% of the lecanemab group and 11.3% of the placebo group.

The most common adverse events in the lecanemab group were reactions to intravenous infusions and abnormalities on their MRIs, such as swelling and bleeding in the brain called amyloid-related imaging abnormalities, or ARIA, which can become life-threatening.

Some people who get ARIA may not have symptoms, but it can sometimes lead to hospitalization or lasting impairment.

And the frequency of ARIA appeared to be higher in people who had a gene called APOE4, which can increase the risk of Alzheimer's disease or other dementias.

ARIAs "were numerically less common" among non-APOE4 carriers, the study showed.

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The drug's prescribing information includes a warning about ARIA, the FDA says.

The trial results also indicated that about 0.7% of participants in the lecanemab group and 0.8% of those in the placebo group died, corresponding to six deaths in the lecanemab group and seven in the placebo group.

Prior to the FDA's decision, some advocacy groups, including the Alzheimer's Association, lobbied to speed up lecanemab's approval.

“We believe, based on the totality of the positive data from the clinical trials of this treatment, that the FDA should approve it.

Published, peer-reviewed results show that lecanemab will provide patients in the early stages of Alzheimer's disease with more time to participate in daily life and live independently.

It could mean many more months of recognizing your spouse, children and grandchildren," said María Carrillo, the group's chief scientific officer, in a statement days before the FDA's decision.

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He added that the Alzheimer's Association hopes the Centers for Medicare & Medicaid Services will "move quickly" to cover the drug and "review its coverage decision that currently blocks access to this treatment."

CMS determines whether to cover FDA-approved therapies based on whether it believes they are safe and effective.

Carrillo says the Alzheimer's Association "has submitted a formal application asking CMS to provide full and unrestricted coverage for FDA-approved Alzheimer's treatments."

In 2021, the FDA approved the drug Aduhelm for early-stage Alzheimer's disease, but that FDA decision has been mired in controversy since a congressional investigation found last week that the FDA's "atypical collaboration" for approving the high-priced Alzheimer's drug was "rift" with irregularities."

Before Aduhelm, the FDA had not approved a new therapy for the condition since 2003.

More than 6.5 million people in the United States are living with Alzheimer's disease, according to the Alzheimer's Association, and that number is expected to rise to 13.8 million by 2060.

“This medicine is not for everyone”

Expedited FDA approval was expected, said Dr. Richard Isaacson, director of the Alzheimer's Prevention Clinic at the Florida Atlantic University Schmidt College of Medicine Center for Brain Health.

Isaacson said that lecanemab may be "another tool" in his toolbox to combat Alzheimer's disease.

“I will prescribe this drug to the right person, at the right dose, and in a very controlled way, but this drug is not for everyone,” he said.

“First I would do genetic testing for APOE4.

I would have a frank conversation with my patients,” she said.

"If someone is having side effects, if someone is taking blood thinning medication, if someone is having a problem, they should discuss this with the treating doctor and they should seek medical attention immediately."


Source: cnnespanol

All news articles on 2023-01-06

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