Page 78 - BusinessWest May 1, 2023

Making Progress
New Alzheimer’s Drug Awaits Approval, Spurs Hope
“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.”
In January, the U.S. Food and Drug Administration approved Leqembi (lecanemab-irmb) via the Accelerated Approval pathway for the treatment of Alzheimer’s disease. Leqembi is the second of
a new category of medications approved for Alzheimer’s disease that target the fundamental pathophysiology of the disease. According to the FDA, these medications represent an important advancement in the ongoing fight to effectively treat Alzheimer’s disease.
“Alzheimer’s disease immeasurably incapacitates the lives of those who suffer from it and has devastating effects on their loved ones,” said Dr. Billy Dunn, director of the Office of Neuroscience
in the FDA’s Center for Drug Evaluation and Research. “This treat- ment option is the latest therapy to target and affect the underlying disease process of Alzheimer’s, instead of only treating the symp- toms of the disease.”
Alzheimer’s disease is an irreversible, progressive brain disor- der affecting more than 6.5 million Americans that slowly destroys memory and thinking skills and, eventually, the ability to carry out simple tasks. While the specific causes of Alzheimer’s are not fully known, it is characterized by changes in the brain — including amy- loid beta plaques and neurofibrillary, or tau, tangles — that result in loss of neurons and their connections. These changes affect a per- son’s ability to remember and think.
Leqembi was approved using the Accelerated Approval pathway, under which the FDA may approve drugs for serious conditions where there is an unmet medical need and a drug is shown to have an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients.
Researchers evaluated Leqembi’s efficacy in a double-blind, placebo-controlled study of 856 patients with Alzheimer’s disease. Treatment was initiated in patients with mild cognitive impairment
or mild dementia and confirmed presence of amyloid beta pathol- ogy. Patients receiving the treatment had significant dose- and time- dependent reduction of amyloid beta plaque, with patients receiving the approved dose of lecanemab every two weeks having a statisti- cally significant reduction in brain amyloid plaque from baseline to week 79 compared to the placebo arm, which had no reduction of amyloid beta plaque.
These results support the accelerated approval of Leqembi, which is based on the observed reduction of amyloid beta plaque, a marker of Alzheimer’s disease. Amyloid beta plaque was quantified using positron emission tomography imaging to estimate the brain levels of amyloid beta plaque in a composite of brain regions expect- ed to be widely affected by Alzheimer’s disease pathology compared to a brain region expected to be spared of such pathology.
According to McKnight’s Long-Term Care News, neurologists in the U.S. have a strong interest in prescribing the Leqembi, with the majority of 73 specialists surveyed saying they would prescribe the treatment if the government fully approves it.
The March 2023 survey, from Spherix Global Insights, found that a healthy proportion of neurologists had already begun pre- scribing Leqembi within a month of commercial availability, while most have chosen to wait for the FDA’s decision when it reviews the request by Eisai, the drug’s manufacturer, for traditional approval on July 6. If traditional FDA approval is granted, nearly all of the surveyed specialists said they planned to prescribe the treatment, mostly within the year following the greenlight, Spherix reported.
The prescribing informa- tion for Leqembi includes a warning for amyloid-related imaging abnormalities
Drug
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