Leqembi (Lecanemab) Is Now Approved For Alzheimer’s Treatment: What To Know

The FDA’s full approval of Leqembi (lecanemab-irmb) has made it one of the few infusions that can be used for Alzheimer’s disease. Continue reading to learn more about how Leqembi works and what makes it different from other Alzheimer's drugs.

What is Leqembi?

Leqembi is an intravenous (IV) infusion prescribed for early Alzheimer’s disease. It contains the active drug lecanemab-irmb and is used to slow the progression of Alzheimer’s disease in patients who have mild cognitive impairment or mild dementia — meaning those who are still in the early stages of dementia or who are experiencing some cognitive defects that do not significantly impair their daily lives.

Alzheimer’s disease results from an accumulation of beta-amyloid plaques in the brain, which damage nerve cells. Leqembi belongs to the amyloid beta-directed monoclonal antibodies drug class and works to slow the decline of Alzheimer’s Disease in its early stages by reducing the buildup of these plaques.

When was Leqembi approved by the U.S. Food and Drug Administration (FDA)?

On January 6, 2023, Leqembi received full FDA approval through the Accelerated Approval pathway for the treatment of Alzheimer’s disease after meeting its primary and secondary endpoints with statistically significant results (“endpoint” here refers to the specific outcome or result that was used to assess the effectiveness of a medication during a clinical trial). It joined the new wave of medications that targets the fundamental pathophysiology of Alzheimer's disease and have received traditional approval, including Aduhelm (aducanumab).  

As a recently authorized medication, Leqembi may not be widely available yet since many facilities, particularly those that don’t specialize in infusion therapy, often take longer to add a new drug into their formulary. 

Is Leqembi offered at Local Infusion?

Yes, Local Infusion is ready to offer Leqembi in all of its locations once a patient is referred. 

How does Leqembi work? 

Although research hasn't  fully uncovered the specific causes of Alzheimer’s disease, typically it is recognized by alterations in the brain. These alterations include the presence of amyloid beta plaques and neurofibrillary (tau) tangles, which lead to the loss of neurons and their connections. This pathological process significantly impacts a person's memory and cognitive abilities. Leqembi works by reducing amyloid beta plaques in the brain which, in turn, slows down the progression of Alzheimer’s disease. 

READ MORE: 

• Leqembi (Lecanemab) vs Aduhelm (Aducanumab) For Alzheimer's: What's The Difference? 
• Leqembi (Lecanemab) vs Donanemab For Alzheimer's: What's The Difference?

What is the success rate of Leqembi?

In 2022, researchers from Eisai and Biogen (the manufacturers of Leqembi) published the results of Clarity AD (the phase 3 clinical trial) in The New England Journal of Medicine, which showed that, in comparison with a placebo, Leqembi slowed down the rate of cognitive decline and reduced the buildup of amyloid beta plaques by approximately 59.1 centiloids (a unit used to measure the extent of amyloid burden in the brain).

On reducing amyloid-β levels…

Leqembi  demonstrated efficacy in reducing brain amyloid-β levels. In an over 18-month period of Leqembi treatment, approximately 68% of the treated patients exhibited complete removal of amyloid-β from their brains. This was confirmed through the use of amyloid positron-emission tomography (PET) imaging, a brain imaging technique. 

On reducing tau…

At the same time, measurements of "plasma markers of phospho-tau species," substances present in the blood which was carried out by PET and cerebrospinal fluid (CSF) biomarkers of Alzheimer’s disease, showed comparable reductions to those observed in brain amyloid-β levels. Thus, it is possible that Leqembi might also be impactful on tau, a substance related to amyloid-β and which is closely associated with the cognitive decline and memory loss seen in Alzheimer's disease.

One of the potential reasons why Leqembi had a high success rate was due to the fact that it targeted amyloid-β better than other treatments for Alzheimer's disease. However, it does come with certain limitations, the most notable of which is that it can’t address cognitive impairment in older ages. 

How long does treatment with Leqembi take?

The prescribed dose for Leqembi is 10 mg/kg, which should be diluted and administered as an intravenous infusion lasting about 1 hour. This infusion is administered once every 2 weeks. If a scheduled infusion is missed, it’s important that a patient receives the subsequent dose as soon as possible. 

Also, it is important to confirm the presence of amyloid beta pathology before receiving Leqembi. 

What are the potential side effects of Leqembi?

Infusion-related reactions

According to Leqembi’s prescribing information, it may cause reactions in patients either during the infusion or shortly after. For this reason, there is a recommended observation time following Leqembi infusions, during which you will be monitored by your infusion provider for any signs or symptoms of reaction. Some of the infusion-related reactions a patient may experience include: 

• Chills
• Body aches
• Joint pain 
• Fever
• Shortness of breath 
• Lightheadedness
• Racing heart rate

If you experience any of the above symptoms, inform your healthcare providers or caregivers immediately. 

Your provider may also administer allergy medicines, anti-inflammatory medicines, or steroids to help prevent infusion-related reactions.

Serious side effects 

Amyloid Aria

Leqembi can cause serious side effects like amyloid related imaging abnormalities (ARIA) — ARIA with edema (ARIA-E) or ARIA with hemosiderin deposition (ARIA-H). 

While this serious, life-threatening side effect is typically asymptomatic and only detectable on brain MRIs, potential symptoms may include: 

• Vision changes
• Seizures 
• Dizziness
• Headache 
• Nausea
• Confusion
• Difficulty walking 

ARIA commonly occurs as temporary brain swelling that resolves over time. Some patients may experience brain bleeding in small spots, and in some rare occasions brain bleeding can occur in larger areas of the brain. 

Some have a genetic risk factor (ApoE ε4 Homozygotes) that may cause them to have an increased risk for ARIA. Talk to your  healthcare professionals about testing for ApoE ε4 status before you begin Leqembi. 

Some medications (e.g., anticoagulant medication and supplements) can increase a patient’s risk for larger areas of brain bleeding. It’s important to inform your healthcare provider of all the medications and supplements you’re on so they can check if any increase your risk of ARIA.

Your healthcare provider will also do magnetic resonance imaging (MRI) scans prior to the start of your treatment and during your treatment to check for ARIA. 

Intracerebral hemorrhage 

Another neurological side effect of Leqembi is serious intracerebral hemorrhage, which is a type of stroke that occurs when a blood vessel ruptures and bleeds into the brain tissue.

How much does Leqembi cost?

Leqembi by Eisai Inc and Biogen Inc (BIIB.O) has an annual list price of $26,500. However, the actual out-of-pocket amount of each patient will vary depending on their individual insurance coverage and their usage of Medicare and Medicaid services. Be sure to inquire about co-pay assistance if cost is of concern to you as many patients will qualify for additional assistance and even $0 copay depending on eligibility. This program is sponsored by Eisai Inc. 

READ MORE: How Much Does Leqembi (Lecanemab) Cost?

Interested in learning more about Alzheimer’s treatment at Local Infusion?

Local Infusion offers modern, state-of-the-art centers with private suites, designed with your comfort in mind.

From questions on what to expect in your first treatment, to providing financial guidance and support, a dedicated Infusion Guide works with you and your physician to provide clear answers and assistance every step of the way. Plus, we handle everything having to do with prior authorization.

We’ll reach out within hours of a physician referral and get you digitally on board in less than two minutes, allowing our staff more time to focus on you.

Should you have questions regarding pricing and insurance, our team will work with you to provide financial assistance support and minimize costs, providing a simple and stress-free experience.