On Jan. 6, the U.S. Food and Drug Administration (FDA) granted accelerated approval to lecanemab (Eisai/Biogen) for the treatment of early Alzheimer’s with confirmation of elevated amyloid. This is the second approved drug that changes the course of Alzheimer’s by slowing its progression at the early stages of the disease.
Alzheimer’s — a progressive, degenerative and fatal brain disease — is the most common cause of dementia.
“The Alzheimer’s Association welcomes and celebrates this action by the FDA. We now have a second approved treatment that changes the course of Alzheimer’s disease in a meaningful way for people in the early stages of the disease,” said Alzheimer’s Association president and CEO Joanne Pike, Dr.P.H. “By slowing progression of the disease when taken in the early stages of Alzheimer’s, individuals will have more time to participate in daily life and live independently. This could mean more months of recognizing their spouse, children and grandchildren. This could also mean more time for a person to drive safely, accurately and promptly take care of family finances and participate fully in hobbies and interests.”
“While this news is exciting, without insurance and Medicare coverage of this class of treatments, access will be limited to only those who can afford to pay out-of-pocket,” Pike said. “The Alzheimer’s Association has submitted a formal request asking CMS to remove the requirement that Medicare beneficiaries be enrolled in a clinical trial in order to receive coverage of FDA-approved Alzheimer’s treatments.”
“Americans living with Alzheimer’s disease are entitled to FDA-approved therapies, just as are people with conditions like cancer, heart disease and HIV/AIDS. And, they deserve the opportunity to assess if an FDA-approved treatment is right for them.”
The Alzheimer’s Association, chief science officer Maria C. Carrillo, Ph.D., also welcomed the approval.
“This second accelerated approval of an Alzheimer’s treatment is a milestone achievement. The Alzheimer’s Association remains committed to advancing a diverse portfolio of potential treatment avenues, and exploring methods for combining approaches for future combination therapies.”
“The progress we’ve seen in not only this class of treatments, but also in the diversification of treatment types and targets over the past few years, is exciting and provides real hope to those impacted by this devastating disease,” Carrillo said.
The Alzheimer’s Association is a worldwide voluntary health organization dedicated to Alzheimer’s care, support and research. Our vision is a world without Alzheimer’s and all other dementia®. Visit alz.org or call 800.272.3900. To learn more about the programs and services offered locally, visit alz.org/hudsonval
