New prescription drug approved for early Alzheimer’s disease

A new medicine that slows the progression of early Alzheimer’s disease was approved on July 26 by the Food and Drug Administration and is the first amyloid-targeting drug to gain full FDA approval.

The medicine, called Lecanemab, is marketed as Leqembi. It is manufactured by Eisai Co., Ltd., a Japanese pharmaceutical company headquartered in Tokyo, and Biogen Inc., an American biotechnology company based in Cambridge, Mass.

Leqembi is an antibody designed to remove sticky deposits of a protein called amyloid beta from the brains of Alzheimer's patients. More than six million Americans have Alzheimer's, according to the Alzheimer's Association.

The FDA’s decision to approve the new drug marks a milestone for the disease that has eluded drugmakers' efforts for decades. According to FDA trial data, the drug slows progression of early-stage Alzheimer’s by 27%.

Dr. R. Scott Turner, a neurology professor and director of the Memory Disorders Program at Georgetown University, talked about the effectiveness of the drug during a recent online presentation sponsored by AARP. The recording of the presentation can be viewed here.

Dr. Turner explained that the new drug is important because it allows patients more time to participate in daily life activities and remain independent. He has been impressed with the trial data and response from patients, stating though the drug will not cure a patient, it decreases how rapidly symptoms manifest.

There is no single diagnostic test that can determine if a person has Alzheimer's disease so physicians use a variety of approaches and tools to help make a diagnosis, Dr. Turner said, including medical history, mental status tests, physical and neurological exams, biofluid (CSF and blood) tests and brain imaging.

Most importantly, a physician can confirm the presence of beta-amyloid plaques in the brain by performing a PET scan or lumbar puncture. Once beta-amyloid plaques are discovered, a doctor will also do a magnetic resonance imaging (MRI) scan before starting treatment, he explained.

The price tag for the drug is $26,500 a year. The Centers for Medicare & Medicaid Services (CMS) announced they will cover Leqembi as long as an individual's physician enrolls them in a CMS-approved registry. Additionally, there is an Leqembi Copay Assistance Program at 833.453.7362 for financial information and support.

Leqembi is given intravenously every two weeks, and patients are monitored for side effects.

AARP will again collaborate with Insight Memory Care on Oct. 12 in a hybrid event featuring author Scott M. Rose, who will discuss his book, "We Danced, Our Story of Love and Dementia," at 6 p.m. at The Kensington Falls Church assisted living facility. This is a free, open discussion to learn about the dementia journey from a caregiver's perspective. Click here for more information and to register to attend.