(Credit: Eisai)

Leqembi (Credit: Eisai)

The Food and Drug Administration on Friday approved the experimental Alzheimer’s disease drug Leqembi (lecanemab) for clinical use in patients in the early stages of disease.

Leqembi is a monoclonal antibody that targets amyloid plaques in the brain, which are widely thought to contribute to the progression of dementia. Made by Eisai and Biogen, it is delivered using repeat infusions. In making its decision, the FDA relied on clinical trial data, which showed a reduction in brain amyloid burden for participants with mild cognitive impairment or mild dementia who took Leqembi. Patients also had “moderately” less decline, by 27%, in measures of cognition and function over an 18-month period.

“Alzheimer’s disease immeasurably incapacitates the lives of those who suffer from it and has devastating effects on their loved ones,” said 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.”

A landmark approval

With few treatments for Alzheimer’s available, the FDA’s decision is a milestone for dementia patients, advocates said.

“We now have a second approved treatment that changes the course of Alzheimer’s disease in a meaningful way for people in the early stages of the disease,” Alzheimer’s Association President and CEO Joanne Pike, DrPH, said in a statement. “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.”

An exciting prospect for memory care 

Some long-term care clinicians said they are energized by the news of a much-needed new treatment. Leqembi is the second drug in its class to receive an FDA greenlight. 

“I am certainly excited to see a new medicine approved for the treatment of dementia reach the market,” said Jim Altrichter, BA, RN, National VP-clinical services for Anthem Memory Care, Lake Oswego, OR, which operates and develops memory care communities in nine states. 

Altrichter has read the clinical trials studies that the FDA used in its approval review, and said he is encouraged by the unique way that the new anti-amyloid drug targets and affects an underlying cause of Alzheimer’s disease to potentially slow its progress.

“For people who are diagnosed with mild cognitive impairment or mild dementia, a conversation with their medical provider about lecanemab and the potential benefits of this medicine would be an important step I would recommend,” he told McKnight’s Clinical Daily

CMS to review Medicare coverage

Eisai on Friday said it has set the “U.S. launching price” of Leqembi at $26,500 per year. The company estimated a per-patient-per-year value of treatment in the United States at $37,600, but said it decided to use the wholesale acquisition cost in order to “to promote broader patient access, reduce overall financial burden, and support health system sustainability.”

That would track with the $28,000 per year cost for Aduhelm, which was reduced by maker Biogen from an initial cost of $56,000.

In light of the new approval, the Centers for Medicare & Medicaid Services said it may rethink how it covers anti-amyloid monoclonal antibodies for the treatment of Alzheimer’s disease. That could mean a big difference in access for patients, considering current Medicare restrictions. CMS last year confined coverage of Leqembi’s predecessor, aducanumab (Aduhelm), and other such drugs in the class to clinical trial participants only. 

But the evidence for Leqembi’s benefits have been widely viewed as more clear-cut than that of Aduhelm, whose approval was shadowed by doubts regarding efficacy, safety and high cost. Patient advocates have clamored for CMS to reconsider its decision and provide full coverage of FDA-approved dementia drugs.

“CMS is examining available information and may reconsider its current coverage based on this review,” the agency said in a statement following Leqembi’s approval.

“At CMS, we will continue to expeditiously review the data on these products as they become available and are committed to timely access to treatments, including drugs, that improve clinically meaningful outcomes,” said CMS Administrator Chiquita Brooks-LaSure.

Prescribing considerations

The FDA used its accelerated approval pathway to greenlight the drug. This pathway allows expedited review of drugs for serious conditions where there is an unmet medical need and when the drug is “reasonably likely to predict a clinical benefit to patients.”

Patients and clinicians who wish to consider the use of Leqembi will need to weigh the drug’s benefits against its risks. The recommended dosage is 10 mg/kg administered intravenously once every two weeks. Eligible patients should have confirmed presence of amyloid beta brain pathology. Leqembi’s most common side effects in clinical trials were infusion-related reactions such as flu-like symptoms, nausea, vomiting and changes in blood pressure. The drug also was associated with headache and amyloid-related imaging abnormalities (ARIA), according to Eisai. Three deaths have also been associated with the clinical trial.

“ARIA usually does not have symptoms, although serious and life-threatening events rarely may occur,” the FDA noted. These include brain swelling and bleeding. To watch for such issues, Eisai recommends “enhanced clinical vigilance” for ARIA during the first 14 weeks of treatment.