How FDA Approved Alzheimer’s Drug Leqembi is Game Changer?

Alzheimer’s disease is a progressive neurodegenerative disorder and the leading cause of dementia. It is characterized by the accumulation of amyloid-beta plaques and tau tangles in the brain, resulting in cognitive decline, memory loss, and behavioral changes.

Leqembi (lecanemab) is a newly developed drug for Alzheimer’s disease that shows promise in slowing disease progression and improving symptoms.

Mechanism of Action

Leqembi is a monoclonal antibody designed to target and clear amyloid-beta plaques, which are believed to contribute to the development of Alzheimer’s disease. By binding to these plaques, Leqembi helps to remove them from the brain, thereby potentially slowing disease progression and enhancing symptoms.

Development History

Leqembi was jointly developed by Eisai and Biogen. Initial clinical trials of Leqembi took place in 2015. In 2021, the FDA granted accelerated approval for Leqembi as a treatment for Alzheimer’s disease. Accelerated approval allows the FDA to approve drugs for severe conditions that offer superior benefits compared to existing treatments, even if complete efficacy data is not yet available.

In 2023, Leqembi received full FDA approval based on the findings of a confirmatory clinical trial, which demonstrated its effectiveness in slowing the progression of Alzheimer’s disease.

FDA Approval and Clinical Trials

Leqembi’s approval by the FDA stemmed from two clinical trials. The first trial, Clarity AD, involved 856 patients with mild cognitive impairment or mild dementia. It revealed that Leqembi effectively slowed the progression of Alzheimer’s disease compared to the placebo group, with patients on Leqembi experiencing a slower decline in cognitive function.

alzheimer’s drug leqembi
Alzheimer’s Drug Leqembi

The second trial, PRIME, enrolled 1,132 patients with mild cognitive impairment or mild dementia. Results showed that Leqembi significantly reduced the number of amyloid-beta plaques in the brain compared to the placebo group.

Side Effects of Leqembi

Although Leqembi is generally well-tolerated, there are potential side effects. Commonly reported side effects include headaches, nausea, and vomiting. In some cases, brain swelling, brain bleeding, and allergic reactions have been reported.

Cost Considerations

The specific cost of Leqembi has not been disclosed yet, but it is anticipated to be relatively expensive. Similar drugs targeting amyloid-beta plaques, like Aducanumab (Aduhelm), have been associated with high costs.


Leqembi represents a promising new treatment for Alzheimer’s disease, being the first FDA-approved drug targeting amyloid-beta plaques. While it demonstrates generally favorable tolerability, it may lead to some side effects. The cost of Leqembi remains undisclosed but is expected to be substantial.

Future Prospects

As an innovative treatment for Alzheimer’s disease, Leqembi holds significant potential. Ongoing research is necessary to determine its long-term efficacy and safety. Nevertheless, Leqembi stands as a potential breakthrough in the field, offering hope for improved Alzheimer’s treatment outcomes.

FAQ About Leqembi Drug

What is Leqembi?

Leqembi is a medication that belongs to a class of drugs called monoclonal antibodies. It is specifically designed to target and remove abnormal protein aggregates called amyloid plaques in the brain. These plaques are believed to play a role in the progression of Alzheimer’s disease.

How does Leqembi work?

Leqembi works by binding to the amyloid plaques in the brain and facilitating their clearance from the body. It specifically targets a protein called beta-amyloid, which forms these plaques. By removing the plaques, Leqembi aims to slow down the progression of Alzheimer’s disease and potentially improve cognitive function.

What is Leqembi used for?

Leqembi is used for the treatment of Alzheimer’s disease. It is specifically indicated for individuals with mild to moderate forms of the disease. The goal of Leqembi treatment is to slow down the cognitive decline associated with Alzheimer’s and improve patients’ quality of life.

Who can take Leqembi?

Leqembi is typically prescribed for individuals with mild to moderate Alzheimer’s disease. However, the specific eligibility criteria for Leqembi treatment may vary, and it is important to consult with a healthcare professional to determine whether Leqembi is suitable for an individual’s specific condition and medical history.

What are the side effects of Leqembi?

Common side effects of Leqembi may include reactions at the injection site, such as redness, swelling, or itching. Other potential side effects may include headaches, falls, diarrhea, and confusion. It is essential to discuss the potential risks and side effects of Leqembi with a healthcare provider before starting the treatment.

How is Leqembi administered?

Leqembi is administered through intravenous (IV) infusion. It is typically given as a 1-hour infusion every 4 weeks. The infusion is performed in a medical setting, such as a clinic or a hospital, under the supervision of healthcare professionals.

What is the cost of Leqembi?

The cost of Leqembi can vary depending on various factors such as the country, healthcare system, and insurance coverage. It is best to consult with the prescribing healthcare provider, pharmacist, or insurance provider to obtain accurate information regarding the cost of Leqembi in a specific situation.

Is Leqembi covered by insurance?

Insurance coverage for Leqembi can vary depending on the insurance plan and the country’s healthcare system. Some insurance plans may cover a portion or all of the cost of Leqembi, while others may have specific criteria or require prior authorization. It is advisable to contact the insurance provider to determine the coverage details for Leqembi.

What are the long-term effects of Leqembi?

The long-term effects of Leqembi are still being studied as it is a relatively new medication. Clinical trials have primarily focused on the short-term safety and efficacy of Leqembi. Long-term studies are ongoing to assess its effects on slowing down the progression of Alzheimer’s disease and to monitor any potential long-term side effects.

Is Leqembi a cure for Alzheimer’s disease?

Leqembi is not considered a cure for Alzheimer’s disease. It is designed to slow down the progression of the disease and potentially improve cognitive function in individuals with mild to moderate Alzheimer’s. It is important to have realistic expectations about the potential benefits of Leqembi and to understand that it does not offer a complete cure for the condition.

What are the risks of taking Leqembi?

Taking Leqembi may pose certain risks, including potential side effects and adverse reactions. Some individuals may experience infusion-related reactions, which can range from mild to severe. There may also be risks associated with the use of monoclonal antibodies in general. It is crucial to discuss these risks with a healthcare professional before starting Leqembi treatment.

What are the benefits of taking Leqembi?

The primary benefit of taking Leqembi is its potential to slow down the progression of Alzheimer’s disease and improve cognitive function in individuals with mild to moderate forms of the disease. By targeting and removing amyloid plaques in the brain, Leqembi aims to preserve cognitive abilities and enhance patients’ quality of life.

What are the alternatives to Leqembi?

There are several alternative treatments and approaches to managing Alzheimer’s disease, including other medications approved for the treatment of the condition. These alternatives may include cholinesterase inhibitors, such as donepezil, rivastigmine, or galantamine, and an N-methyl-D-aspartate (NMDA) receptor antagonist called memantine. Non-pharmacological interventions, such as cognitive stimulation and lifestyle modifications, may also be considered.

What is the future of Leqembi?

The future of Leqembi and its role in the treatment of Alzheimer’s disease is still being researched and evaluated. Ongoing clinical trials and studies aim to gather more data on its long-term efficacy, safety, and potential benefits. Further research may also explore the use of Leqembi in combination with other therapies or for other indications related to amyloid-related diseases.

Where can I get more information about Leqembi?

To obtain more information about Leqembi, it is advisable to consult healthcare professionals, such as doctors, neurologists, or pharmacists, who can provide accurate and up-to-date information specific to an individual’s situation. Additionally, reputable medical websites, scientific journals, and official pharmaceutical company websites can serve as valuable sources of information about Leqembi and its use in the treatment of Alzheimer’s disease.