A relative slowing of cognitive decline continues for up to two years in patients who stop taking the recently authorized Alzheimer’s disease drug Leqembi (lecanemab), according to the latest analysis of clinical trial findings from drugmaker Eisai.
Leqembi received approval in January by the Food and Drug Administration to treat qualified patients with early disease. The drug and its predecessor Aduhelm are monoclonal antibodies that target Alzheimer’s brain plaques. Leqembi was originally shown to slow measures of cognition and function by 27% over an 18-month period.
Slower disease progression
In the new analysis, phase 2 clinical trial subjects took Leqembi for 18 months and then stopped taking it between nine and 59 months before resuming treatment, according to a report on the analysis by CNBC. When compared to a placebo group, some measures of disease progression remained slower in the Leqembi group relative to a placebo group.
“The disease was set back for a certain amount of time,” David Russell, director of clinical research for the Institute for Neurodegenerative Disorders, told the news outlet. Patients got one more year before they progressed to a moderate disease compared to those who weren’t treated, he said.
Other scientists have argued that the effects of the drug are not significant enough to be clinically meaningful.
Medicare coverage of Leqembi is severely restricted to clinical trials, although the Veterans Health Administration has announced that it would cover limited treatment among its patient population.
Eisai is waiting for a review of its request to convert the accelerated approval of its drug to a traditional approval, potentially setting it up for coverage reconsideration by the Centers for Disease Control and Prevention. That could lead to greater patient access beyond veterans and clinical trial participants. The review is scheduled for July 6.
Related articles:
FDA approves new drug Leqembi to treat early Alzheimer’s disease
VHA to cover new Alzheimer’s drug Leqembi, despite CMS’s restraint
Alzheimer’s drug lecanemab has ‘moderate’ effect on cognitive decline, new trial data show
