FDA Approval of Alzheimer’s Drug Stirs Up Heated Debate

The FDA on June 7 delivered its much-anticipated approval of Biogen Inc.’s Aduhelm (aducanumab-avwa), immediately stirring up a furor over its high cost, reigniting doubts about its effectiveness, and spurring speculation about how public and private payers will approach coverage for the first novel treatment approved for Alzheimer’s disease since 2003.

Alzheimer’s, which affects more than 6 million Americans and tens of millions of people worldwide, is marked by progressive cognitive and functional decline that eventually results in death. It kills more people than breast and prostate cancers combined and, along with other forms of dementia, is expected to cost the U.S. $355 billion this year alone, according to the Alzheimer’s Association.

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