FDA Approves Groundbreaking Alzheimer’s Drug

By laura Freeman

Early diagnosis of Alzheimer’s Disease has just become more urgent.

“Now that we have a therapy that can slow the progression of Alzheimer’s Disease (AD) by 25 to 35 percent, we can finally do something to delay the damage,” said David Geldmacher, MD, FACP, neurologist and director of UAB’s Division of Memory Disorders and Behavioral Neurology.

Clinical trials conducted at UAB gathered evidence that led to the accelerated limited approval of Lecanemab, commercially known as Leqembi, in January. Further trials confirmed the effectiveness of the drug in slowing progression when administered to patients early in the course of the disease. That led to the Leqembi becoming the first new AD therapy to receive full FDA approval in 20 years.

This approval has also opened the door to Medicare coverage of the medication, with the provisions that patients must be in the early stages of AD, and they are required to participate in a registry that will continue to track the benefits of the drug and its safety.

“The drug is a protein antibody that binds to amyloid plaques and is administered as an infusion in a healthcare setting every two weeks for 18 months,” Geldmacher said. “About 26 percent of patients may benefit from over-the-counter Tyle-