Last week, the U.S. Food and Drug Administration converted Leqembi (lecanemab-irmb), the first drug indicated to treat adult patients with Alzheimer’s by slowing the disease, to traditional approval following a determination that a confirmatory trial verified clinical benefit.
"The decision for full FDA approval of lecanemab marks a major milestone in the fight against Alzheimer’s Disease,” said researcher and clinician David Wolk, MD, Co-Director of the Institute on Aging and Director of the Alzheimer’s Disease Research Center.
“In addition to being the first approval in ~20 years, it is the first drug to demonstrate clear alteration of the biology of the disease and modify the speed of progression,” he explained. “While there remains much work to be done, this foothold in more specific molecular therapies for AD will usher in an era of precision medicine that I believe will greatly accelerate progress in the field over the next 5-10 years. This is a time to be very hopeful!”