FDA greenlights Leqembi® for the treatment of early Alzheimer’s disease.

This month we are thrilled to join the Alzheimer’s Association in celebrating the U.S. Food and Drug Administration (FDA) action to grant traditional approval of Leqembi® (lecanemab) for the treatment of early Alzheimer's disease with confirmation of elevated amyloid beta.

“[This] action is the first verification that a drug targeting the underlying disease process of Alzheimer’s disease has shown clinical benefit in this devastating disease,” said Teresa Buracchio, acting director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research. “This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease.”

“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 protein component of amyloid plaques. Large numbers of such plaques in the grey matter of the brain are a characteristic feature of Alzheimer’s disease. Leqembi is administered twice monthly through intravenous infusion and in a Phase 3 clinical trial, the drug delayed cognitive decline by 5.3 months compared to placebo after 18 months of treatment. Further delays in progression are anticipated with extended time under treatment.

Leqembi has been on the market since January 2023, when it received accelerated approval from the FDA. However, to this point access has been blocked by Medicare coverage policies. With this new approval — and through the tireless efforts of the Alzheimer’s Association, bipartisan members of Congress, state attorneys general, clinicians, and, most importantly, advocates from communities across the country — that obstruction has now been eliminated. The Centers for Medicare & Medicaid Services (CMS) followed up the FDA announcement with an announcement of their own affirming that treatment with Leqembi will be covered through Medicare.

“We appreciate today’s action by CMS... 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,” said Joanne Pike. “Now, CMS’s policy must be implemented effectively to minimize clinician burden and maximize patient access. We are committed to working with CMS, the physician community, our health system partners and other community partners to ensure a smooth rollout.”

This news is especially important to those of us in Tarrant County.

Alzheimer's Association statistics show that the number of Texas seniors with Alzheimer’s disease is expected to reach 490,000 by 2025, a 22.5% increase since 2021. And the Texas Department of State Health Services found that nearly one quarter (23%) of the state’s Alzheimer’s care recipients are in Tarrant County — the highest percentage among Texas' 254 counties.

If you or a loved one is experiencing memory changes, we strongly encourage you to contact a health care provider for a thorough evaluation and diagnosis and to discuss treatment options. Leqembi is only approved for people confirmed by a doctor to be in the mild early stages of Alzheimer’s disease, making early detection and diagnosis critical.

At Overture Home Care, we understand that facing an Alzheimer’s disease diagnosis can be overwhelming. As authorized providers of Dementia Live® training, we empower our caregivers to provide you and your family with thoughtful, empathetic support and assistance through all stages of Alzheimer’s disease. To learn more about the services we provide, please call us for a free consultation at (817) 887-9401 or (214) 887-9401. Our phones are staffed 24/7 and we look forward to assisting you.