In a very welcome move, Biogen and Eisai’s Alzheimer’s disease drug has been granted traditional approval by the US Food and Drug Administration (FDA).
The drug, Leqembi (lecanemab-irmb), was authorised for use in patients with mild cognitive impairment (MCI) or early-stage Alzheimer’s disease earlier this year through the accelerated approval pathway, under which the FDA may approve drugs for serious conditions where there is an unmet medical need.
This decision was based on phase 2 data showing that Leqembi reduced the accumulation of amyloid beta plaque in the brain – a defining feature of Alzheimer’s disease. However, only US residents with appropriate medical insurance, or those who could afford to pay for it directly, could access the drug.
The FDA’s latest decision is expected to significantly expand access by enabling the Centers for Medicare and Medicaid Services (CMS) to provide wider insurance coverage under the US government’s Medicare plan, which covers most older people.
Eisai’s supplemental biologics application for approval under the traditional pathway was supported by data from its phase 3 confirmatory Clarity AD clinical trial.
The study met its primary endpoint, reducing clinical decline by 27% on the global cognitive and functional scale – Clinical Dementia Rating-Sum of Boxes – compared with placebo at 18 months.
All multiplicity-controlled secondary endpoints also showed highly statistically significant results compared with placebo, the companies said, including other measures of cognition and daily function.
Teresa Buracchio, acting director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said: “[The] action is the first verification that a drug targeting the underlying disease process of Alzheimer’s disease has shown clinical benefit in this devastating disease.
“This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease.”
Affecting more than 6.5 million Americans, Alzheimer’s disease is an irreversible, progressive brain disorder that slowly destroys memory and thinking skills and, eventually, the ability to carry out simple tasks.
Haruo Naito, chief executive officer at Eisai, said: “The FDA approved Leqembi under the traditional approval pathway, making Leqembi the first and only approved anti-amyloid Alzheimer’s disease treatment shown to reduce the rate of disease progression and to slow cognitive impairment in the early and mild dementia stages of the disease.”
“Eisai will diligently work to educate physicians on the safe and appropriate use of Leqembi to maximise its benefit to people living with early Alzheimer’s disease and their families,” Naito added.