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June 7, 2021, 12:00 p.m. EDT

FDA approves Biogen’s Alzheimer’s drug, the first to slow the disease

Biogen drug approved after facing doubts over whether it slows progression of memory-robbing disease

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By Joseph Walker


Bloomberg News/Landov

The first drug promising to slow the memory-robbing march of Alzheimer’s disease was approved by U.S. health regulators, a watershed after years of research and billions of dollars in investment.

Its sale offers hope to millions of people dealing with Alzheimer’s and their caregivers, given the lack of good options for treatment. Yet the impact of the drug, which has the molecular name aducanumab, may be limited. Doctors who say they will prescribe the drug caution it won’t help all patients, particularly those with more advanced disease. Some patients eligible for treatment may face $10,000 or more in annual out-of-pocket costs, health insurer Cigna Corp. estimates.

“Currently available therapies only treat symptoms of the disease; this treatment option is the first therapy to target and affect the underlying disease process of Alzheimer’s.”

U.S. Food and Drug Administration

The drug is a potential blockbuster for its maker Biogen Inc. /zigman2/quotes/201531540/composite BIIB -2.89%  Its approval comes at a critical time for the biotech, which is coping with declining sales and the loss of patent protection for its biggest-selling drug, Tecfidera, a pill for multiple sclerosis.

Don’t miss : Biogen’s pivotal moment: Will the FDA approve the experimental -- and controversial -- Alzheimer’s-disease drug aducanumab?

Biogen has said it expects aducanumab sales to be modest this year as it launches the drug, and to start growing thereafter. Analysts polled by FactSet project sales of $62.7 million in 2021, $603.2 million in 2022 and $1.6 billion in 2023. The drug’s list price wasn’t immediately available.

An expanded version of this report appears at WSJ.com .

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/zigman2/quotes/201531540/composite
US : U.S.: Nasdaq
$ 242.90
-7.23 -2.89%
Volume: 1.30M
Nov. 26, 2021 1:00p
P/E Ratio
23.77
Dividend Yield
N/A
Market Cap
$36.74 billion
Rev. per Employee
$1.36M
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