CHICAGO, May 25, 2023 — The Alzheimer's Association and members of the Association's Early Stage Advisory Group submitted comments to the FDA Peripheral and Central Nervous System Drugs Advisory Committee, urging it to recommend traditional approval of Leqembi™ (lecanemab, Eisai). Leqembi was granted accelerated approval in January 2023 and the FDA will complete its review for traditional approval by July 6, 2023. 

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. Specifically, Leqembi reduced decline by 27% compared with placebo at 18 months. This difference in decline translated into a 5.3 month slowing of disease progression over the course of the trial.

“People living with Alzheimer’s deserve the opportunity to slow the progression of this fatal disease and the science is clear that Leqembi provides that opportunity,” said Joanne Pike, DrPH, Alzheimer’s Association president and chief executive officer. “We expect the Advisory Committee recognizes the indisputable benefit this treatment allows and that it will recommend traditional FDA approval.”

There’s consensus in the scientific and medical communities about the clinical benefits of thorough removal of amyloid from the brain for people living with mild cognitive impairment (MCI) and early-stage Alzheimer’s disease. More than 200 clinicians and researchers asserted the Clarity AD trial demonstrated an “unequivocal effect.” 

In comments to the FDA Advisory Committee, four members of the Alzheimer’s Association Early Stage Advisory Group expressed the impact FDA-approved treatments can have on their lives. 

“Many of us feel that our diagnoses have helped us to reorganize our priorities such that we intend to live with more purpose for as long as we can. Living purposefully means living independently. It means being present and actively enjoying the relationships we most cherish. It means being able to appreciate milestones,” the group wrote. “One of us got to see his granddaughter start high school, and he has pledged to be there when she graduates. That is the significance and promise of these treatments to us.” 

Despite the proven benefits of Leqembi and other treatments in this class, the Centers for Medicare & Medicaid Services (CMS) continues to severely limit access to treatments for people with early Alzheimer’s. Even if the FDA grants Leqembi traditional approval, CMS has stated it will continue to limit access to the treatment by requiring enrollment in a treatment registry as a term of coverage which will be a barrier to patients living with this fatal disease.

The Peripheral and Central Nervous System Drugs Advisory Committee will meet on June 9 to review the scientific data. Alzheimer’s Association president and CEO, Dr. Joanne Pike, will provide oral comments.