In a major development for patients and the biotechnology industry, the U.S. Food and Drug Administration approved the use of a new drug, Aduhelm (adu

New Alzheimer’s drug is 1st of its kind to be FDA approved

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2021-06-08 08:00:05

In a major development for patients and the biotechnology industry, the U.S. Food and Drug Administration approved the use of a new drug, Aduhelm (aducanumab), for treating early Alzheimer's disease.

"This is the first time we have any new approved treatment for Alzheimer's disease over the past two decades," said Dr. Babak Tousi, who led Cleveland Clinic's study site for the multicenter clinical trials.

But the new drug, made by the biotechnology company Biogen, has been marred by controversy throughout its development history, with prominent Alzheimer's disease specialists arguing the drug's benefits are unlikely to outweigh the risk of serious side effects.

In a statement announcing the approval, the FDA acknowledged the controversy surrounding and "differing perspectives" surrounding Aduhelm.

The FDA will require Biogen to conduct a new, large clinical trial to determine the drug's benefit, and reserves the right to rescind the approval in the future. Meanwhile, patients will have access to the drug, which is given by intravenous infusion.

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