FDA Approves Leqembi: First Drug to Slow Alzheimer's Disease Progression

A beacon of hope has emerged in a landscape often marred by heartbreaking stories of memory loss and cognitive decline. The U.S. Food and Drug Administration (FDA) has converted Leqembi (lecanemab-irmb) to traditional approval for the treatment of adult patients with Alzheimer's disease. 

The drug was originally approved in January 2023 under the Accelerated Approval pathway. This pathway allows the FDA to approve drugs for serious conditions where there is an unmet medical need, based on clinical data demonstrating the drug's effect on a surrogate endpoint—in the case of Leqembi, reducing amyloid plaques in the brain—that is reasonably likely to predict a clinical benefit to patients.

The FDA's approval of Leqembi is a milestone moment, marking a significant stride in the battle against this debilitating disease. It heralds a new chapter in Alzheimer's treatment, opening doors to the potential of slowing down the condition's progression and giving some hope for millions grappling with the disease.

According to the Centers for Disease Control and Prevention (CDC), an estimated 6.5 million Americans are living with Alzheimer's disease, which does not have a cure. However, researchers are hopeful about this medication. 

Babak Tousi, MD, neurogeriatrician for Cleveland Clinic, explained that the medication does not treat symptoms of the disease but helps slow its progression. 

When we say Alzheimer's, it's a large spectrum, so there are very early stages to very advanced dementia. So, at this point, there are no findings supporting the use of this medication for people with moderate to late-stage dementia. This is for people in the very early stages of the disease.

Regarding success rates, results from an 18-month clinical trial showed participants who received the medication had a 27% reduction in amyloid beta plaque. The drug is designed to reduce amyloid beta plaque in the brain. Amyloid beta plaque has been linked to Alzheimer's disease.

Dr. Tousi said that number may sound small, but he believes it's a good place to start.

It seems we have achieved some treatment. We can affect the disease trajectory. It is a small benefit, but it's still a benefit. We can slow it down and I think it's one of many to come down the road to hopefully target it, so that's the biggest step for us.

Leqembi works by reducing amyloid plaques that form in the brain. Amyloid plaques are a defining pathophysiological feature of Alzheimer's disease. The drug is administered by monthly intravenous infusion.

The FDA's decision to convert Leqembi to traditional approval is a significant milestone for treating Alzheimer's disease and other types of dementia. It provides patients with a new treatment option that has been shown to be effective in slowing disease progression.

Teresa Buracchio, acting director of the Office of Neuroscience in the FDA's Center for Drug Evaluation and Research, says this is the first verification that a drug targeting the underlying disease process of Alzheimer's disease has shown clinical benefit in this devastating disease.

This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer's disease.

Alzheimer's Disease: A Progressive Brain Disorder

Alzheimer's is a progressive brain disorder that causes memory loss and other cognitive decline. It is the most common cause of dementia, a general term for loss of memory and other cognitive abilities severe enough to interfere with daily life.

Of the estimated 6.5 million Americans have Alzheimer's disease or other dementias, nearly 5 million are aged 65 and older. Alzheimer's and other dementias are the sixth leading cause of death in the United States. Dementia, however, is a global problem.

• United States: Alzheimer's and other dementias are the sixth leading cause of death in the United States. An estimated 6.5 million Americans have Alzheimer's disease or other dementias, and this number is expected to grow to 13.8 million by 2050. The cost of caring for people with Alzheimer's and other dementias is estimated to be $355 billion annually in the United States.
• Canada: Alzheimer's and other dementias are the seventh leading cause of death in Canada. An estimated 750,000 Canadians have Alzheimer's disease or other dementias, and this number is expected to grow to 1.4 million by 2050. The cost of caring for people with Alzheimer's and other dementias is estimated to be $100 billion per year in Canada.
• United Kingdom: Alzheimer's and other dementias are the fifth leading cause of death in the United Kingdom. An estimated 850,000 people in the U.K. have Alzheimer's disease or other dementias, which is expected to grow to 1.6 million by 2050. The cost of caring for people with Alzheimer's and other dementias is estimated to be $26 billion annually in the U.K.
• Germany: Alzheimer's and other dementias are the third leading cause of death in Germany. An estimated 1.9 million people in Germany have Alzheimer's disease or other dementias, and this number is expected to grow to 2.8 million by 2050. The cost of caring for people with Alzheimer's and other dementias is estimated to be $40 billion per year in Germany.

Alzheimer's and Long-Term Care

People with Alzheimer's disease or other dementias often require supervision and long-term health care. The cost of caring for people with Alzheimer's and other dementias is estimated to be $355 billion annually in the United States. Traditional health insurance, including Medicare, does not pay for most of this cost. Long-Term Care Insurance will pay for long-term care due to memory loss, and Medicaid will pay for an individual with little or no income and assets. 

• What Is Long-Term Care Insurance and What Does It Cover?

Many families face a crisis situation when a parent or other loved one has dementia and needs supervision and long-term health care. When an individual lacks Long-Term Care Insurance, personal income, and assets will pay for care or adult children will step in and provide care despite being untrained or prepared for the role. As a result, family caregivers face their own crisis attempting to juggle caregiving with their jobs and family responsibilities. 

Causes of Dementia Unknown

The specific causes of Alzheimer's are not fully known, but it is characterized by changes in the brain, including the formation of amyloid beta plaques and neurofibrillary tangles. These changes result in the loss of neurons and their connections, which leads to a progressive decline in cognitive function.

While there is no cure for Alzheimer's disease, this new drug may help slow the progression of the disease and improve quality of life. Other treatments include lifestyle changes and supportive care.

If a loved one is experiencing memory loss or other cognitive changes, it is important to see a doctor to get a diagnosis. Early diagnosis and treatment can help to improve the quality of life and delay the progression of the disease.

Quality long-term care services will also maintain a better quality of life. Experts suggest that adding Long-Term Care Insurance to your retirement plan will help address the costs and burdens of aging and long-term care, including dementia care. Most people get coverage in their 40s or 50s when they still enjoy good health since you cannot purchase LTC Insurance when you already have significant health issues.