Silver Spring, MD—The new Alzheimer’s disease drug, Leqembi, is expected to be available by the third week of January, according to the companies who sought approval.
The approval of Leqembi was granted to Eisai R&D Management Co., Ltd., which worked with Biogen Inc. to develop lecanemab-irmb. It will be available during or before the week of January 23, 2023, according to an Eisai press release. The company said it decided to initially price the drug at $26,500 per year for the wholesale acquisition cost, which is below the quantified societal value.
“Leqembi is the second of a new category of medications approved for Alzheimer’s disease that target the fundamental pathophysiology of the disease. These medications represent an important advancement in the ongoing fight to effectively treat Alzheimer’s disease,” according to a press release from the FDA. The application was given Fast Track, Priority Review, and Breakthrough Therapy designations.
“Alzheimer’s disease immeasurably incapacitates the lives of those who suffer from it and has devastating effects on their loved ones,” stated Billy Dunn, MD, director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research. “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.”
The Accelerated Approval pathway allows the FDA to permit drugs for serious conditions when 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,” according to an FDA press release.
In a study published in the New England Journal of Medicine, researchers suggested that the accumulation of soluble and insoluble aggregated amyloid-beta might initiate or potentiate pathologic processes in Alzheimer’s disease. The Yale School of Medicine–led authors pointed out that lecanemab, a humanized immunoglobulin G1 monoclonal antibody that binds with high affinity to amyloid-beta soluble protofibrils, is being tested in patients with early Alzheimer’s disease.
Their 18-month, multicenter, double-blind, phase III trial involved patients aged 50 to 90 years with early Alzheimer’s disease, defined as mild cognitive impairment or mild dementia due to Alzheimer’s disease, with evidence of amyloid on positron emission tomography (PET) or by cerebrospinal fluid testing.
The researchers randomly assigned 1,795 participants in a 1:1 ratio to receive IV lecanemab (10 mg/kg of body weight every 2 weeks) or placebo. The change from baseline at 18 months in the score on the Clinical Dementia Rating–Sum of Boxes (CDR-SB; range, 0 to 18, with higher scores indicating greater impairment) was considered the primary endpoint. Secondary endpoints of importance were the change in amyloid burden on PET, the score on the 14-item cognitive subscale of the Alzheimer’s Disease Assessment Scale (ADAS-cog14; range, 0 to 90; higher scores indicate greater impairment), the Alzheimer’s Disease Composite Score (ADCOMS; range, 0 to 1.97; higher scores indicate greater impairment), and the score on the Alzheimer’s Disease Cooperative Study–Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-MCI-ADL; range, 0 to 53; lower scores indicate greater impairment).
The researchers reported that the mean CDR-SB score at baseline was approximately 3.2 in both groups, adding that results indicate that the adjusted least-squares mean change from baseline at 18 months was 1.21 with lecanemab and 1.66 with placebo (difference, –0.45; 95% CI, –0.67 to –0.23; P <.001).
“In a substudy involving 698 participants, there were greater reductions in brain amyloid burden with lecanemab than with placebo (difference, –59.1 centiloids; 95% CI, –62.6 to –55.6),” according to the report. “Other mean differences between the two groups in the change from baseline favoring lecanemab were as follows: for the ADAS-cog14 score, –1.44 (95% CI, –2.27 to –0.61; P <.001); for the ADCOMS, –0.050 (95% CI, –0.074 to –0.027; P <.001); and for the ADCS-MCI-ADL score, 2.0 (95% CI, 1.2 to 2.8; P <.001). Lecanemab resulted in infusion-related reactions in 26.4% of the participants and amyloid-related imaging abnormalities with edema or effusions in 12.6%.”
The authors concluded that lecanemab “reduced markers of amyloid in early Alzheimer’s disease and resulted in moderately less decline on measures of cognition and function than placebo at 18 months but was associated with adverse events.
The study team is calling for longer trials to determine the efficacy and safety of lecanemab in early Alzheimer’s disease.
The recommended dosage of the drug is 10 mg/kg administered intravenously once every 2 weeks to eligible patients with confirmed presence of amyloid-beta pathology prior to initiating treatment. Prescribing information for Leqembi includes a warning for amyloid-related imaging abnormalities, which are known to occur with antibodies of this class.
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