The U.S. Food and Drug Administration has approved a controversial Alzheimer’s treatment, the first that promises to slow the disease’s destructionin the brain, not just improve symptoms.
The drug, aducanumab, is also the first new Alzheimer’s treatment approved since 2003. It doesn’t cure or reverse Alzheimer’s disease, which affects more than 6 million people in the United States and is projected to affect nearly 13 million people by 2050.
The drug’s path to approval hasn’t been smooth. In 2019, aducanumab was nearly scrapped after it appeared unlikely to succeed in two large clinical trials. But after reanalyzing more data that came in later, the drug’s developer, Biogen, which is based in Cambridge, Mass., saw signs that indicated the drug might work after all, and decided to pursue FDA approval (SN: 12/5/19).
Still, today’s decision concerns some doctors and scientists who see the FDA’s move as premature because they aren’t convinced that the drug, also known as Aduhelm, actually works. Approving a drug that’s not effective would set Alzheimer’s research back and offer patients false hope, those experts argue.
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