UAB was involved in clinical trials that led to an accelerated approval of the drug lecanemab, commercially known as Leqembi, in January 2023. A UAB Alzheimer’s expert discusses the therapy and what full approval means for the AD field.The United States Food and Drug Administration approved a new therapy that slows the progression of Alzheimer’s disease in patients with early or mild forms of cognitive impairment or dementia. The drug lecanemab, commercially known as Leqembi, is the first new AD therapy to receive full approval by the FDA in over 20 years.
The University of Alabama at Birmingham Division of Memory Disorders and Behavioral Neurology and the Alzheimer’s Disease Center were involved in clinical trials that led to an accelerated, or limited, approval of Leqembi by the FDA in January. Since then, further clinical trials provided evidence that the new therapy slowed the progression of AD in patients by 25 percent to 35 percent.
“While the new therapy does not restore memory or reverse the symptoms of Alzheimer’s disease, it is a significant step in slowing the progression of the disease,” said David Geldmacher, M.D., professor of neurology in the UAB Marnix E. Heersink School of Medicine and Clinical Core director for the Alzheimer’s Disease Center. “However, a medicine that slows the progression of Alzheimer’s helps people maintain their independence, which is a goal for nearly everyone.”
The drug focuses on reducing brain amyloid, a sticky protein that accumulates in AD. Earlier studies of similar therapies showed a decrease in amyloid but were less clear on the effects on cognitive decline. Developers submitted Leqembi for full approval after published results showed patients treated with the therapy had less cognitive function decline than those in the placebo group.
While the FDA approval is an important step in AD treatment, Geldmacher emphasizes that the therapy is only for those who are clinically diagnosed as having early or mild AD. The medication is administered via IV infusion every two weeks, which poses a significant time commitment. Additionally, patients will need to be monitored for potential serious side effects, including bleeding or swelling in the brain.
“The approval is a milestone in Alzheimer’s treatment and is a result of intense research; however, the research is far from over,” Geldmacher said. “This approval will help usher in a new era in our field and opens the door for new ways of treating AD, maintaining brain health, and reducing the disability and caregiving challenges associated with Alzheimer’s disease.”
Upon Leqembi’s limited approval in January, Medicare decided not to offer coverage. However, with the FDA’s full approval, Medicare announced it would expand coverage of the therapy. Coverage will significantly broaden the availability of the therapy since most of the AD population is over the age of 65 and on a fixed or limited income. To qualify for Medicare coverage, patients will need to be enrolled in a registry so the researchers can continue to study the safety and effectiveness of the medicine in routine use.
While UAB doctors have prescribed Leqembi since its limited approval in January, UAB Hospital has expanded staffing in the memory clinics to prepare for the increased demand for services that are expected to result from the FDA’s decision.