FDA Approves New Treatment for Alzheimer's Disease: Presence of Beta Amyloid Must Be Confirmed Before Treatment

January 6, 2023

A new treatment for Alzheimer’s disease, lecanemab, was approved today by the U.S. Food and Drug Administration (FDA). Lecanemab has been shown to slow the progression of Alzheimer’s for patients who are in early stages of the disease.

Lecanemab is a monoclonal antibody that helps eliminate beta amyloid, a protein that builds up in the brains of those with Alzheimer’s disease. A recent clinical trial showed that lecanemab reduced beta amyloid buildup, slowing the speed at which patients lost memory and cognitive function.

The prescribing information for the new drug instructs physicians to “confirm the presence of amyloid beta pathology prior to initiating treatment.” PET scans are effective in detecting the buildup of beta-amyloid plaque in the brain, thus helping identify patients who may benefit from Alzheimer’s disease treatments such as lecanemab.

“Lecanemab can slow cognitive decline in eligible patients,” said SNMMI President Munir Ghesani, MD, FACNM, FACR. “In order to ensure that this new drug is administered to only those patients who are likely to benefit from it, the SNMMI recommends that amyloid PET scans be performed first to show that those patients have amyloid plaque buildup in their brain. PET scans should also be performed on patients after they have been taking lecanemab to ensure that the amount of amyloid plaque has decreased.”

SNMMI plans to engage with the Centers for Medicare & Medicaid Services to ensure that beta amyloid PET imaging is covered and reimbursed for this indication. “This will increase the likelihood that lecanemab will be accessible to patients who are likely to benefit from it,” noted Ghesani.

Lecanemab was approved through the FDA’s Accelerated Approval pathway. This pathway gives approval for drugs that treat serious or life-threatening diseases and fulfill an unmet need, despite some uncertainty regarding their clinical benefits. It is manufactured by Eisai and Biogen.

More than six million Americans live with Alzheimer’s disease, and it is the sixth leading cause of death among adults in the United States. In 2022, Alzheimer’s disease was estimated to cost the American economy $321 billion.