Why a new FDA-approved Alzheimer’s drug is a milestone in mental health

Because the world’s population is living longer, the risk neurodegenerative diseases inextricably linked to aging. For this reason, science is rapidly working on therapeutic options against dementia. Within this framework, promising medical advances have been reported in recent weeks.

At the beginning of July US Food and Drug Administration (FDA) gave full approval for monoclonal antibodies for Alzheimer’s disease treatment. This medicine is lekanemab (known by the trade name Lekambi), developed by Eisai and Biogen Laboratories, which acts on beta-amyloid protein deposits and reduces cognitive decline by 27% in the initial stages of pathology.

In 2021, the Food and Drug Administration (FDA) also green-lit Biogen’s aducanumab (under the name Aduhelm). But recent approval Lekambimark before and after in area mental healthAccording to an expert from the Mount Sinai Health System, USA.

“The full approval of Lekambi represents milestone for the medical community and patients struggling with Alzheimer’s disease,” the doctor said. Mary Sanoprofessor of psychiatry and director of the Center Alzheimer’s research at the Icahn School of Medicine at Mount Sinai.

“Until now, No one considered Alzheimer’s disease to be curable.”emphasized the specialist, emphasizing the importance of FDA approval.

Alzheimer’s disease (AD) This is the most common form of dementia and is estimated to be more than 55 million people in the world They live with this and other dementias. In addition, by 2050 that number could triple to more than 150 million, according to a study published in The Lancet Public Health.

Lekambi (lekanemab) is a monoclonal antibody drug for reduce the accumulation of beta-amyloid plaques in the brain, which are a defining feature of Alzheimer’s disease.

Icahn School of Medicine expert on Mount Sinai explained, “Amyloid beta has been identified as a key factor in Alzheimer’s disease.”

Although The underlying causes of Alzheimer’s disease are not yet fully understood.accumulations of beta-amyloid and other proteins, such as tangles tauwere associated with memory loss and cognitive function in patients.

Lekambi has received FDA approval for the treatment of both mild cognitive impairment and mild dementia. They are about early stages of the diseasecharacterized by the ability of patients to carry out daily activities, although they may experience memory lapses (such as forgetting words and the arrangement of objects) and other cognitive difficulties.

“In clinical trials that confirmed the full approval of Lekambi, the drug demonstrated statistically significant reduction in cognitive decline compared to placebo. Therefore, patients can expect to slow down the loss of their cognitive functions,” Dr. Sano said.

The outcomes measured in the study were related to daily life activities that early stage of the diseasemay interfere with the occurrence of neurodegenerative pathology, such as paying bills, performing banking transactions, or performing certain tasks with digital devices.

“The demonstrated effect is modest, but stable in all respects. I do not want to exaggerate that this is the beginning and end of the treatment,” the specialist pointed out and added: “I am not saying that this is a great effect and that the person returns to 100% normal. But before Lekambi’s research, we had other monoclonal antibodies, and we didn’t see such a stable income“.

These benefits were observed at the third month of treatment and were maintained until the 18th month at the end of the study.

Prior to Lekambi, the prevailing view of patients diagnosed with mild dementia (MCI) was “wait and see,” notes Dr. Sano: “Professionals may be reluctant to initiate active treatment in patients who are very autonomy”.

“There is an obstacle to changing our culture, but it clearly surmountable“, assured the Alzheimer’s disease expert. “The only difference we have to consider is this: people don’t stay with mild dementia foreverwe need to change the culture to address this early on,” he concluded.

In a randomized, double-blind, placebo-controlled study of 1,795 people, Lekambi showed: significant reduction in the clinical classification of dementia (CDR)cognitive and functional measure, compared to placebo.

In patients treated with Lekambi, there was a decrease 27% in CDR on 18 months.

This difference was observed after six months and increased every three months. In terms of beta-amyloid load, as measured by the Centiloids scale, the Lekambi group reduced plaque count by 55.5 points at 18 months, while the placebo group increased by 3.6 points. Statistical significance was reached after three months.

Who can access treatment in the US

The Centers for Medicare and Medicaid Services (CMS) announced in early July that Lekambi is eligible for Medicare Part B coverage. One requirement is documentation of beta-amyloid plaques in the brain, which requires diagnostic imaging studies, Mount Sinai Medical Centers said. .

“If you don’t have amyloid, that means it’s a drug that you can’t use even if you have memory symptoms or other cognitive problems,” Dr. Sano said.

Keep reading: