CLEVELAND — On Thursday, the U.S. Food and Drug Administration granted full approval the Alzheimer’s drug, lecanemab, which is being sold by its manufacturers, Biogen and Eisai, under the brand name, Leqembi. It is considered a milestone in the treatment of the disease. 

What You Need To Know

  • Leqembi has received full FDA approval for the treatment of early-stage Alzheimber's disease

  • The new drug is intended to slow the progression of the disease

  • Leqembi is not a cure, but is bringining hope to many Alzheimer's patients and their caregivers

  • Full FDA approval of Leqembi means Medicare could cover it for more people seeking treatment

Leqembi is for patients with early-stage Alzheimer’s disease. According to researchers, it's the first medication that's been shown to slow the progression of Alzheimer's cognitive decline.

It is not a cure, but is considered a meaningful advancement for Alzheimer's patients who may be able to maintain more independence in their daily lives. The newly approved drug also comes with risks, including brain swelling and bleeding.

Full FDA approval clears the way for broader Medicare coverage of those seeking the treatment.

Approximately 6.5 million Americans are living with Alzheimer's disease, according to the Centers for Disease Control and Prevention.

“When we say Alzheimer’s, it’s a large spectrum, so there are very early stages to very advanced dementia,” said Dr. Babak Tousi, neurogeriatrician for Cleveland Clinic. “So, at this point, there are no findings supporting the use of this medication for people with moderate to late-stage dementia. This is for people in the very early stages of the disease.”

Tousi was the primary investigator of the Cleveland Clinic's studies of lecanemab. Watch the interview above for more information.