Alzheimer's / Dementia

7/7/2023 | By Annie Tobey

Patients with early stage Alzheimer’s disease have a new treatment option. On July 6, 2023, the U.S. Food and Drug Administration (FDA) granted traditional approval to lecanemab (Eisai/Biogen), brand name Leqembi, for patients confirmed to be in early stage Alzheimer’s disease with elevated amyloid beta. The treatment was granted accelerated approval in January 2023, but this is the first Alzheimer’s treatment to receive traditional approval that changes the underlying course of the disease.

Alzheimer’s is a progressive, degenerative and fatal brain disease, the most common cause of dementia. An estimated 6.7 million Americans age 65 and older are living with Alzheimer’s dementia. More than 11 million people act as caregivers of people with Alzheimer’s disease or other dementias.

The Alzheimer’s Association addresses lecanemab

“This treatment, while not a cure, gives people in the early stages of Alzheimer’s disease more time to maintain their independence and do the things they love,” said Joanne Pike, DrPH, Alzheimer’s Association president and CEO. “While we continue efforts to discover new targets and test new treatments, people living with this fatal disease deserve the opportunity to discuss and make the choice with their doctor if an FDA-approved treatment is right for them.”

“Leqembi works by targeting amyloid beta, the primary component of amyloid plaques, which are a disease-defining hallmark in the brains of people with Alzheimer’s disease,” explains a media statement from the Alzheimer’s Association. “Well-conducted clinical trials clearly demonstrate that removing amyloid from the brain provides measurable, meaningful benefit in people with early Alzheimer’s. In a Phase 3 clinical trial, Leqembi delayed cognitive decline by 5.3 months compared to placebo after 18 months of treatment, at a time when such delays are most valuable to the individual. Further delays in progression are anticipated with extended time under treatment. It is administered twice monthly through intravenous infusion.”

Side effects of Leqembi include amyloid-related imaging abnormalities (ARIA), typically a temporary swelling and/or bleeding in certain areas of the brain that usually resolves over time. ARIA does not usually cause symptoms, but in a low number of cases it can be serious. The FDA also recommended genetic testing. People with two copies of a well-known Alzheimer’s risk gene may be more at risk of ARIA.

Medicare coverage

Following the FDA decision, the Centers for Medicare & Medicaid Services (CMS) announced their plan to enable access to FDA traditionally approved Alzheimer’s treatments.

“We appreciate today’s action by CMS and their efforts to reduce physician burden in their registry approach,” said Joanne Pike, Alzheimer’s Association president and CEO. “It is clear that CMS leaders have listened to experts, advocates, people living with Alzheimer’s, and families. It is reflected in their plan for delivering coverage of traditionally approved treatments proven to deliver meaningful benefit.”

The Alzheimer’s Association reminds people of the importance of an early diagnosis.

“An early and accurate diagnosis of Alzheimer’s has a positive impact on health outcomes, access to treatments, and eligibility for research trials, plus vital support and information services,” said Maria C. Carrillo, Ph.D., Alzheimer’s Association chief science officer. “CMS also said they will cover amyloid confirmation diagnostics, removing an obstacle to accurate diagnosis that far too many individuals have faced.”

Related: Benefits of an early Alzheimer’s diagnosis

CAPTIONS (photos courtesy of the Alzheimer’s Association – Eastern North Carolina Chapter):

  1. Inside the brain: Concept of neurons and nervous system. Two neurons transmitting information.
  2. Alzheimer’s disease research at The Robert H. and Terri Cohn Research Building at Rush University Medical Center in Chicago, Ilinois.

Annie Tobey