FDA approves Alzheimer’s drug

A new Alzheimer’s drug, lecanemab, that slows the disease’s progress, is officially on the market.

The U.S. Food and Drug Administration (FDA) has granted full approval for use of a new drug, lecanemab, to slow the progress of Alzheimer’s disease. Lecanemab, a monoclonal antibody treatment, dissolves plaques that can build up between brain cells, or neurons, and are widely thought to cause Alzheimer’s symptoms.

The drug from Eisai Co. Ltd. and Biogen has been especially effective in the early stages of buildup and is now available for mild cognitive impairment due to Alzheimer’s disease.

How effective is lecanemab for treating Alzheimer’s disease?

Lecanemab had been accepted for accelerated approval by the FDA. Results from the Clarity AD phase 3 clinical study showed disease progression slowed by 26% after 18 months in those who received lecanemab infusions every other week.

“This is a very significant step forward for our field. Lecanemab is the first medication with solid evidence that it is really modifying the course of this disease and, at least as many of us think, treating the underlying causes of this disease” said Gregory E. Cooper, M.D., Ph.D., neurologist and director of the Norton Neuroscience Institute Memory Center.

Norton Neuroscience Institute

The Norton Neuroscience Institute Memory Center provides evaluation and care for patients with symptoms of memory loss.

With the largest team of board-certified and fellowship-trained specialists in the Louisville and Southern Indiana region, we help patients and their loved ones find the causes of memory issues, dementia and other brain disorders.

To receive updates about lecanemab and other memory treatments, sign up for our newsletter.

Scientists believe buildup of beta-amyloid plaque in the brain could be responsible for damaging and killing nerve cells. Most researchers believe plaques somehow play a critical role in blocking communication among nerve cells and disrupting processes cells need to survive.

According to the Alzheimer’s Association, more than 6 million Americans are living with the disease. It’s one of the top 10 leading causes of death in the U.S., and the fifth leading cause of death among adults ages 65 or older. While lecanemab is not a cure for people with Alzheimer’s disease, research shows it slows the progression of the disease significantly. For a disease that has been untreatable in the past, the new drug is especially promising.

Access to the new Alzheimer’s drug and next steps

Lecanemab is indicated for those with very early or mild Alzheimer’s disease. An assessment of medical history, MRI and minor blood work are required to determine whether a patient is eligible. Additional testing such as a spinal fluid examination, through a positron emission tomography (PET) scan, and a genetic test can determine the risk of amyloid-related abnormalities appearing in diagnostic imaging tests such as MRIs.

Lecanemab is given by IV infusion every two weeks in an infusion center. The infusion is administered in less than an hour, with extended careful monitoring afterward. Home infusions may be an option after an initial series of center-based infusions. Repeat MRI scans can be completed three to four times during the first year to monitor for any side effects.

Is lecanemab safe?

There are some potential risks to the drug. A quarter of patients will experience a mild reaction to the infusion. Symptoms might include fever, headache, rash, nausea or abdominal discomfort. These symptoms usually can be controlled with over-the-counter medications such as acetaminophen or antihistamines, if necessary.

If you think you may be a candidate for lecanemab, contact your neurologist to discuss eligibility.

Schedule an Appointment

Select an appointment date and time from available spots listed below.