The logo of Eisai Co Ltd is displayed at the company headquarters in Tokyo, Japan, March 8, 2018. (REUTERS/Issei Kato)
Eisai Co. and its partner Biogen Inc. gained initial US regulatory clearance for lecanemab, the first treatment clearly shown to slow the advance of brain-wasting Alzheimer’s disease.
The drug, to be sold under the brand name Leqembi, was approved by the Food and Drug Administration under an accelerated pathway. While the partners have to submit more data to gain full approval, the decision immediately expands treatment options for the millions of patients living with the debilitating condition. The drug will cost $26,500 a year for a person of average weight, according to Eisai.
Biogen shares were halted before the news was released. Eisai’s American depositary receipts rose as much as 12% as of 2:43 p.m. in New York.
Characterized by the presence of toxic brain deposits of a protein called amyloid, Alzheimer’s disease damages the minds and memories of some 6 million Americans. Lecanemab is among a series of drugs aimed at removing those deposits, and while it’s far from a cure, the companies recently found in a final-stage trial that it slowed cognitive decline by 27% over 18 months compared to a placebo in a late-stage trial.
"Alzheimer’s disease immeasurably incapacitates the lives of those who suffer from it and has devastating effects on their loved ones,” said Billy Dunn, 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 is based on data showing the drug’s ability to remove amyloid, and Eisai plans to submit the results showing the impact on cognition to get full FDA approval, the company has said.
The clearance could be a chance for the companies to bounce back after the controversial approval of their earlier Alzheimer’s drug, Aduhelm, in 2021. Outside medical experts advised the FDA not to allow the drug on the market because the results from two big trials conflicted on how the drug impacted brain function. Last week, congressional investigators said in a report that the approval process for Aduhelm was "rife with irregularities,” citing Biogen’s close collaboration with FDA staff.
In contrast, the results from lecanemab’s efficacy trial were unambiguous, though the magnitude of the benefit seen in the company’s 18-month study was modest. The drug also has significant side effects: More than one in five people who received the drug in the final-stage trial experienced brain swelling or brain bleeding, compared to 10% of those on a placebo.
The drug can also cause brain abormalities such as swelling or bleeding that can be seen via imaging, although most of them are linked to only mild symptoms. The most common side effects of the treatment were infusion-related reactions, headache and amyloid-related imaging abnormalities, according to the FDA.
In addition, in an extension phase of the lecanemab trial, two patients on blood thinners died after receiving the drug. Eisai has said that the deaths cannot be attributed to the drug. Eisai also said that information it has so far about a third death in the trial extension, first reported by Science magazine, doesn’t suggest a clear link to drug-related brain swelling or bleeding.
Accelerated approvals are typically given to drugs for cancer and other dire diseases based on promising early results, in order to get medicines to patients sooner while more definitive confirmatory trials are conducted. In an unusual situation, Eisai completed the confirmatory trial for Leqembi prior to the accelerated approval, which will allow it to apply for full approval right away.
The Centers for Medicare and Medicaid Services will expeditiously review the data on these products as they become available, agency administrator Chiquita Brooks-LaSure said in a statement.
