FDA approves 3rd Alzheimer's drug

The FDA handed Biogen and Eisai's new Alzheimer's drug accelerated approval Jan. 6. 

About 6.5 million Americans live with Alzheimer's disease, an "irreversible, progressive brain disorder," according to the FDA. Based on the drug's value and clinical benefit, Eisai said it will price an annual supply of Leqembi (lecanemab) at $26,500, which equals a 200 milligram vial priced at $254.81 and a 500 milligram vial at $637.02. 

The price exceeds what the Institute for Clinical and Economic Review listed as the drug's "cost-effectiveness threshold," which is between $8,500 and $20,600 for a year's supply. Eisai's own per-patient-per-year value is $37,600, the drugmaker said. 

The monoclonal antibody, which is intended to be infused every two weeks, is the third drug to be FDA-approved to treat Alzheimer's since 1993, according to the Alzheimer's Association

"The approval of Leqembi provides new hope to patients with Alzheimer's disease," Christopher Viehbacher, Biogen's CEO, said in a statement. "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. ... Eisai and Biogen have collaborated for nearly a decade to advance research to improve the lives of those suffering from Alzheimer's, and we know that this commitment must and will continue in the fight against Alzheimer's disease."

In a phase 3 trial, the drug Leqembi saw a 27 percent slower cognitive decline among nearly 2,000 study participants, but despite the results, three confirmed trial patient deaths and the controversial history of Biogen's Aduhelm could cast a shadow over the news. 

The first death was reported in late October after the patient experienced swelling and bleeding in the brain, and two more deaths were confirmed by Science in November and December. It's unclear if the drug is tied to the deaths, though. After the second death was reported, Cambridge, Mass.-based Biogen said "no deaths were related to lecanemab," and its co-developer, Tokyo-based Eisai, said the same. 

A research letter published Jan. 4 in the New England Journal of Medicine said the combination of the then-investigational Alzheimer's drug and a clot-busting drug may have led to the cerebral hemorrhages, according to CNN

In the accelerated approval announcement, the FDA did not mention the deaths or the latest study's safety profile results; the agency's decision was based on a phase 2 study of 856 patients with Alzheimer's disease. 

"The results of a phase 3 randomized, controlled clinical trial to confirm the drug's clinical benefit have recently been reported and the agency anticipates receiving the data soon," the FDA said. The phase 2 results "support the accelerated approval of Leqembi, which is based on the observed reduction of amyloid beta plaque, a marker of Alzheimer's disease."

The FDA added that the drug's prescribing information "includes a warning for amyloid-related imaging abnormalities" — which includes hemorrhages — "which are known to occur with antibodies of this class. ARIA usually does not have symptoms, although serious and life-threatening events rarely may occur."

Along with some other safety profile notes, Leqembi is approved to treat patients with the mild cognitive impairment or mild dementia stage of disease, which is "the population in which treatment was studied in clinical trials," the FDA said. 

This label is different from the agency's last Alzheimer's drug approval, Aduhelm, in June 2021, which was marked for wide-label use that led to controversy, a CEO's resignation and a congressional report that blamed both Biogen and the FDA.

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