FDA grants accelerated approval for Alzheimer's treatment
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The FDA has granted accelerated approval for Leqembi for the treatment of Alzheimer’s disease, making it the second approved Alzheimer’s treatment, the agency announced in a press release.
The approval comes after review of phase 3 data, which was published in The New England Journal of Medicine in November 2022. The results showed that Leqembi (lecanemab-irmb, Eisai) reduced markers of amyloid in early AD and resulted in less decline in cognition and function.
“This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer’s, instead of only treating the symptoms of the disease,” Billy Dunn, MD, director of the office of neuroscience at the FDA’s Center for Drug Evaluation and Research, said in the release.
Leqembi was approved under the accelerated approval pathway, which the FDA uses to approve drugs for serious conditions when there is an unmet medical need. The agency stated that Alzheimer’s disease affects more than 6.5 million Americans.
“This is encouraging news, but the approval of lecanemab is just the first step,” Howard Fillit, MD, chief science officer at the Alzheimer’s Drug Discovery Foundation, said in a foundation press release. “Alzheimer’s therapies will only be beneficial to patients if the right drug is given to the right patient at the right time based on their unique disease pathology, and for that we need new and novel diagnostic biomarkers.”
Prescribing information for Leqembi includes a warning for amyloid-related imaging abnormalities (ARIA), which are known to occur with antibodies of the class, the FDA release states. ARIA usually does not have symptoms, although serious and life-threatening events rarely occur.
An additional warning includes risk for infusion-related reactions, with symptoms such as flu-like symptoms, nausea, vomiting and changes in blood pressure.
The Leqembi label states that it is indicated for treatment of AD and should be initiated for those with mild cognitive impairment or mild dementia. In addition, the label states that there are no safety or efficacy data on initiating treatment at earlier or later stages of disease.
“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,” Alzheimer’s Association President and CEO Joanne Pike, DrPH, said in a release from the association. “This could mean more months of recognizing their spouse, children and grandchildren. This could also mean more time for a person to drive safely [and] accurately and promptly take care of family finances and participate fully in hobbies and interests.”
Perspective
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It’s a promising step forward to have a drug that’s available for early Alzheimer’s disease. Whether or not the slowed progression of cognitive deterioration is sustained over longer periods of follow-up and whether the drug allows for maintenance of clinically meaningful functional capacity over time still remains to be seen.
The side effect of amyloid-related imaging abnormalities remains a concern, as does the potential price point of the medication. I’m hoping that drug companies continue to develop even better antibody-based treatment strategies that build on the early successes of lecanemab.
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