FDA ADVISORY COMMITTEE UNANIMOUSLY CONFIRMS EFFICACY AND CLINICAL BENEFIT OF LEQEMBI FOR EARLY ALZHEIMER'S DISEASE

CHICAGO, June 9, 2023 /PRNewswire/ -- Today, an Advisory Committee to the Food and Drug Administration (FDA) unanimously endorsed the efficacy and clinical benefit of lecanemab (Leqembitm, Eisai) as part of the traditional approval process for this treatment.

"The Alzheimer's Association welcomes and celebrates this action by the FDA Advisory Committee to support traditional approval of Leqembi for people with early Alzheimer's," said Joanne Pike, DrPH, Alzheimer's Association president and CEO. "With this action we are one step closer to more people living with Alzheimer's having more time with more of their capabilities intact ? to do the things they want to do and love to do best."

The Alzheimer's Association and members of the Association's Early Stage Advisory Group each submitted comments urging the Advisory Committee to recommend traditional approval of Leqembi, which was granted accelerated approval in January 2023.

"While the thought of a cure for Alzheimer's disease is certainly part of my optimism, I'd like you to know that for me, more time is enough for now. And that is the promise of treatments like lecanemab," said Myra Garcia, member of the Alzheimer's Association Early Stage Advisory Group, to the committee today.

The Alzheimer's Association has strongly advocated for full Medicare coverage for FDA-approved Alzheimer's treatments. Last week, the Centers for Medicare & Medicaid Services (CMS) said Medicare would cover Alzheimer's treatments that receive traditional FDA approval if clinicians register and enter data in a registry. While this is an important signal that CMS wants to improve access to FDA-approved treatments, registry as a condition of coverage is an unnecessary and potentially harmful barrier. Additionally, although traditional approval appears just weeks away, CMS has not shared details relevant to ensuring patients and physicians can enroll with as few barriers as possible, including additional information about the data submission, registry requirements and details about how patients and physicians can enroll.

"We are in full agreement with the FDA Advisory Committee that Leqembi provides clinical benefit and that this benefit outweighs the risks. Now all eyes turn to CMS," Pike said. "Medicare is supposed to be a rock-solid guarantee for Americans, and it is time for CMS to step up and provide Medicare access on the day of an FDA traditional approval. Americans living with Alzheimer's disease deserve access to FDA-approved therapies without barriers, just like people with cancer, heart disease and HIV/AIDS."

The next regulatory step toward traditional approval of the treatment is FDA review. The FDA has granted Priority Review to Leqembi for the traditional approval application, with required action from the agency by July 6, 2023.

Leqembi, an anti-amyloid treatment, changes the course of Alzheimer's and delivers clear clinical benefit for people in the early stages of the disease. By slowing progression in the early stages of Alzheimer's, this treatment will give people more time to participate fully in daily life, participate in important decisions, and live independently. This could mean more time for a person to take care of family finances, and participate in hobbies and interests.

Phase 3 data from the Clarity AD global clinical trial published in the New England Journal of Medicine showed Leqembi met both the primary and all key secondary endpoints for the patient population with highly statistically significant results. As with other anti-amyloid treatments in this class of drugs, Leqembi does have side effects; of note, amyloid-related imaging abnormalities (ARIA), which usually do not cause symptoms, but can be serious.

The current prescriber information for Leqembi (based on accelerated approval) acknowledges the need for real-world evidence and long-term safety data collection. Participation in the Alzheimer's Association's Alzheimer's Network for Treatment and Diagnostics (ALZ-NET) by clinicians and patients is encouraged by the FDA in the prescribing information.

The Alzheimer's Association is here all day, every day for people facing Alzheimer's and other dementia. The Association strongly encourages anyone experiencing memory changes to speak with a health care provider for a thorough evaluation, diagnosis and to discuss treatment options.

Alzheimer's Association
The Alzheimer's Association leads the way to end Alzheimer's and all other dementia ? by accelerating global research, driving risk reduction and early detection, and maximizing quality care and support. Our vision is a world without Alzheimer's and all other dementia. Visit alz.org or call the 24/7 Helpline at 800.272.3900.

SOURCE Alzheimer's Association