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Biotech / Medical : Biogen
BIIB 219.74-1.2%Aug 16 3:59 PM EDT

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From: Sr K6/7/2021 4:38:37 PM
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FDA Approves First New Alzheimer’s Drug in Nearly Two Decades

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

The approval of Aduhelm comes at a critical time for its maker Biogen.PHOTO: ERIN CLARK/BOSTON GLOBE/GETTY IMAGES

Joseph Walker

Updated June 7, 2021 4:11 pm ET

U.S. health regulators approved the first new Alzheimer’s drug in nearly two decades, casting aside doubts about the therapy’s effectiveness.

The approval Monday of the therapy, which has the molecular name aducanumab and will be sold as Aduhelm, marked a watershed in Alzheimer’s drug research after billions of dollars in investment. Maker Biogen Inc. developed the therapy to do what previously approved Alzheimer’s medicines can’t: slow the memory-robbing march of the disease.

The U.S. Food and Drug Administration, explaining its decision, said scientific evidence indicated Aduhelm reduces a sticky substance in the brain called amyloid—which is associated with Alzheimer’s—and is likely to produce a benefit to patients.

The drug’s sale offers hope to millions of people dealing with Alzheimer’s and their caregivers, given the lack of good options for treatment. Yet Aduhelm’s impact 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.

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