An Alzheimer’s drug from Biogen and Eisai has received accelerated approval from the Food and Drug Administration (FDA), the companies and the agency announced on Friday.
Lecanemab appeared to reduce brain amyloid plaque – a marker of Alzheimer’s disease – in an 865-patient study of people with “mild cognitive impairment or mild dementia stage of the disease and confirmed presence of a beta-amyloid pathology” on which the FDA based its decision, the agency says. The drug, also known as Leqembi, is listed for these people in its prescribing information.
Alzheimer’s disease “slowly destroys memory and thinking skills and eventually the ability to perform simple tasks,” according to the FDA press release. In America, more than 6.5 million people have it.
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“This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer’s disease, rather than just treating the symptoms of the disease,” said Office Director Dr Bill Dunn. of Neuroscience at the FDA’s Center for Drug Evaluation and Research, said in a statement.
Warnings regarding amyloid-related imaging abnormalities (ARIA) and infusion-related reactions are included in the Leqembi prescribing information.
ARIA “most often presents as temporary swelling in areas of the brain that typically changes over time and may be accompanied by small bleeding spots in or on the surface of the brain,” according to the FDA. The agency said ARIA “usually has no symptoms, although serious and life-threatening events may rarely occur.”
Those two side effects, along with headaches, were the most common for the drug, according to the FDA.
Eisai recently released phase 3 trial data for Leqembi which the company said it would use to seek FDA approval through the traditional route.
This study also seemed to show that the drug helped some people slow the decline. In it, about 13% of patients had brain swelling and 17% had small brain bleeds.
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Last week, a congressional report found that the FDA’s approval of a similar Alzheimer’s drug called Aduhelm – also from Biogen and Eisai – was “tainted with flaws”, including a number of meetings with staff of an undocumented pharmaceutical company.
The review of the new drug, known chemically as lecanemab, will likely mean most patients won’t start receiving it for months as insurers decide if and how to cover it.
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The drug will cost around $26,500 for a typical year of treatment. Eisai said the price reflects the drug’s benefits in terms of improved quality of life, reduced caregiver burdens and other factors. The company pegged its value at more than $37,000 a year, but said it priced the drug lower to reduce costs for patients and insurers. An independent group that evaluates the value of drugs recently said that the price of the drug should be below $20,600 per year to be profitable.
Biogen CEO Christopher Viehbacher said in a statement that the company is now focused “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”.
Biogen’s stock price rose about 2.8% on Friday following the news. It has increased by about 20% over the past year.
The Associated Press contributed to this report.