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FDA approves the new Alzheimer’s drug, lecanemab.

Therapy should be available in US the week of Jan. 23 or before.

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On Friday, the Food and Drug Administration (FDA) approved the Eisai and Biogen’s amyloid-targeted antibody Alzheimer’s drug, Lecanemab, after it has shown to be able to slow the progression of the disease in its initial stages, during the clinical trials. This brings new hope for patients suffering with the debilitating disease after decades of failure in finding an effective treatment.

The FDA’s approval of LEQEMBI under the Accelerated Approval pathway is an important milestone in Eisai’s four decades of research in Alzheimer’s disease and reflects our continued commitment to alleviating the burden of Alzheimer’s disease for patients and their families.

Haruo Naito, Eisai’s CEO in a press release.

The drug was approved in an accelerated pathway due to a medical need for a medication to treat patients with Alzheimer’s disease. This does not mean that further clinical trials to analyze the side effects would not be conducted. The companies now have the obligation to carry out further clinical trials to confirm the benefits of this new drug or else the drug might be removed from the market.

Alzheimer’s disease involves the accumulation of beta-amyloid protein in the brain. As this protein increases, it clumps together in the brain and it starts to disrupt nerve cell function and ultimately lead to the death of these cells. Lecanemab is an antibody designed to target a toxic form of beta-amyloid that’s prone to clumping, neutralizing the protein and marking it for the immune system to remove it before it can aggregate.

According to Eisai, the drug should be available for US patients in the week of Jan. 23, 2022. The price for the treatment for a whole year would be $26,500. The price might be substantially lower only if the patient receives the drug less frequently than the requested infusion at a dose of 10 mg/kg once every two weeks. This is possible only if the patient achieves a significant reduction in the amount of beta-amyloid plaques under a maintenance regimen.

The approval of LEQEMBI provides new hope to patients with Alzheimer’s disease. Patients at an early stage of the disease and their caregivers can now consider a new treatment option with their doctors. Our focus now is on the path forward, working alongside Eisai with the goal of making LEQEMBI available to patients who may benefit from this treatment as soon as possible.

Christopher A. Viehbacher, Biogen’s president and CEO.

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